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CompletedNCT00871572Updated Apr 24, 2018Results posted

A Study for Participants With Type 2 Diabetes Mellitus

A Phase 2 interventional study of LY2409021 and Placebo in Diabetes Mellitus, Type 2, sponsored by Eli Lilly and Company. Completed at 19 sites in 3 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-04-24.

Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
87
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

This drug is being evaluated for possible treatment of type 2 diabetes mellitus. Participation in this study is expected to last up to 18 weeks. A goal of this study is to determine the safety and effectiveness of LY2409021.

02

Conditions studied

  • Diabetes Mellitus, Type 2

Keywords

  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 87 is close to the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Participants must either be male or a female who cannot become pregnant, who has type 2 diabetes and is either controlling your diabetes through diet and exercise alone, or with diet and exercise taking metformin.
  • If participants are male, participants are willing to talk to the study doctor about birth control options during the study and for 3 months after the last dose of study medication.
  • Participants must have an Hemoglobin A1c (HbA1c) test of 6.5% to 10%
  • Participants must have a body mass index (BMI) between 25 to 40 kilograms/square meter (kg/m²).
  • Participants must be willing and able to test your blood sugar levels at home with a blood sugar meter.
  • Participants must complete a study diary as instructed by your study doctor and staff and return the study diary as instructed by the study doctor.
  • Participants must maintain consistent dietary, physical activity, and sleeping patterns throughout the study.

Exclusion criteria

Exclusion Criteria:

  • Insulin, exenatide, or any diabetic medication other than metformin 3 months prior to screening to control you diabetes,
  • Medications to increase movement in your digestive tract or that slow movement in your digestive tract
  • Over-the-counter drugs or drugs prescribed by your doctor that cause weight loss or high or low blood sugar,
  • Chronically use oral glucocorticoids therapy or have received this type of medication within 8 weeks prior to beginning this study,
  • Class II and III antiarrhythmic agents (commonly used to prevent or relieve an irregular heartbeat),
  • Drugs that damage the liver
  • Fibrates and niacin (both commonly used to treat high cholesterol) more than 1 gram/day (gm/day),
  • Central nervous stimulants, alcohol intake for males that is more than 2 units per day and for females that is more than 1 unit per day [1 unit=12 ounces (oz) or 360 milliliter (mL) of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits].
  • You have had one (1) or more cases of uncontrolled diabetes (very high blood sugars) which required hospitalization in the 6 months prior to the screening visit or have a diagnosis of hypoglycemia (low blood sugar) unawareness.
  • You had two (2) or more emergency room visits or were hospitalized for poor control of your diabetes (for example, keto-acidotic episode) in the last 6 months.
  • Participants have a problem with your stomach such that it empties slowly (diabetic gastroparesis) or you have had gastric bypass (bariatric) surgery.
  • Participants have a personal or family history of pancreatic neoplasia.
  • Participants have abnormal lipids (for example triglycerides).
  • Participants have had problems with your heart in the past 6 months, such as a heart attack, chest pain (angina), heart failure, heart bypass operation, angioplasty (a medical procedure to open a narrow or clogged blood vessel of the heart) or stent insertion (a procedure to insert a wire mesh tube to prop open a blood vessel after angioplasty), a heart rhythm problem, or a stroke.
  • Participants have an elevated or uncontrolled blood pressure.
  • Participant's electrocardiogram (ECG, a test that measures the electrical activity of your heart) is outside the normal limits, as determined by the study doctor.
  • Participants have a problem with your kidneys or are on dialysis.
  • Participants have a problem with your pancreas.
  • Participants must not have nor had liver disease (for example, Hepatitis B or C).
  • Participants have cancer, except for skin cancer or have been in remission (the absence of disease activity) from cancer for less than 5 years.
  • Participants have a serious or uncontrolled health problems (other than type 2 diabetes), blood disorders or laboratory tests that in the opinion of the doctor, could interfere with understanding the results of this study. The doctor will let you know if this applies to you.
  • Participants previously completed or withdrew from this study or any other study investigating LY2409021.
  • Participants are allergic to the study drug or other related drugs. You cannot be in this study if you are a woman and you possibly could become pregnant during this study.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
87 participants (actual)

Study arms

  • Placebo comparator
    Placebo

    Drug: Placebo

  • Experimental
    LY2409021 10 milligrams (mg)

    Drug: LY2409021

  • Experimental
    LY2409021 30 mg

    Drug: LY2409021

  • Experimental
    LY2409021 60 mg

    Drug: LY2409021

Interventions

  • DrugLY2409021

    4 capsules by mouth taken once daily for 12 weeks

  • DrugPlacebo

    4 capsules by mouth once daily for 12 weeks

06

What researchers measure

Primary outcomes

  1. Mean Change in Glycosylated Hemoglobin A1c (HbA1c)

    HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was calculated using a mixed-model repeated measures analysis (MMRM) that included terms for treatment group, baseline HbA1c, metformin use, visit, and visit-by-treatment interaction.

    Time frame: Baseline, Week 12

Secondary outcomes

  1. Change From Baseline Values for Fasting Blood Glucose (FBG)

    LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.

    Time frame: Baseline, Week 12

  2. Change From Baseline for Glucose Area Under the Curve (AUC) From Oral Glucose Tolerance Test (OGTT)

    LS mean was calculated using analysis of covariance (ANCOVA) model that included terms for treatment group, baseline value and metformin use.

    Time frame: Baseline, Week 12

  3. Change From Baseline to Endpoint for Fasting Triglycerides

    LS mean was calculated using ANCOVA model that included terms for treatment group, baseline value and metformin use.

    Time frame: Baseline, Week 12

  4. Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R)

    The DSC-R was a participant completed questionnaire that was designed to assess the presence and perceived burden of diabetes-related symptoms. Participants were asked to recall the last 4 weeks and consider each symptom/item in terms of whether they experienced it and if so, how troublesomeness it was. Participants were to consider troublesomeness of the symptom on a 1 (not at all) to 5 (extremely) point scale. There were a total of 34 items, grouped into 8 subscales: cardiovascular (4 items), psychological-cognitive distress (4 items), psychological-fatigue (4 items), hyperglycemic (4 items), hypoglycemic (3 items), neurological-pain (4 items), neurological-sensory (6 items) and visual (5 items). Sub-domain score calculated as: (sum of item scores) divided by (number of items), scores ranged from 1 to 5. Total score was the sum of all sub-domains and ranged from 8 to 40. Higher scores of total and subscales indicated worsened symptoms.

    Time frame: Baseline, Week 12

  5. Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021)

    The Diabetes Medicines Survey was a participant reported questionnaire consisting of 25 items: perceived effectiveness of diabetes medicines (items 1-10) and physical side-effects (items 11-25). Both domains had a scores range from 1 (all of the time) to 4 (none of the time) and a possible total scores range from 25 to 100. Lower scores for perceived effectiveness items indicated a better perceived effectiveness. Lower scores for physical side-effects items indicated a greater frequency of physical side-effects.

    Time frame: Baseline, Week 12

  6. Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles

    Participants obtained 7-point SMBG values immediately before and 2 hours after each meal and at bedtime. LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.

    Time frame: Baseline, Week 12

  7. Change From Baseline Values for Fasting Insulin

    LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.

    Time frame: Baseline, Week 12

  8. Change From Baseline Values for Fasting Glucagon

    LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.

    Time frame: Baseline, Week 12

  9. Change From Baseline Values for Fasting Glucagon-Like Peptide 1 (GLP-1)

    LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.

    Time frame: Baseline, Week 12

  10. Change From Baseline for Insulin AUC From OGTT

    LS mean was calculated using an ANCOVA that included terms for treatment group, baseline value and metformin use.

    Time frame: Baseline, Week 12

  11. Change From Baseline for C-Peptide AUC From OGTT

    LS mean was calculated using an ANCOVA model that included terms for treatment group, baseline value and metformin use.

    Time frame: Baseline, Week 12

  12. Change From Baseline to Endpoint for Low Density Lipoprotein (LDL)

    Fasting LDL LS mean was calculated using ANCOVA that included terms for baseline and treatment.

    Time frame: Baseline, Week 12

  13. Change From Baseline to Endpoint for High Density Lipoprotein (HDL)

    Fasting HDL LS mean was calculated using ANCOVA that included terms for baseline and treatment.

    Time frame: Baseline, Week 12

  14. Change From Baseline to Endpoint for Non-HDL Cholesterol

    Fasting non-HDL cholesterol LS mean was calculated using ANCOVA that included terms for baseline and treatment.

    Time frame: Baseline, Week 12

  15. Change From Baseline to Endpoint for Total Cholesterol

    Fasting total cholesterol LS mean was calculated using ANCOVA that included terms for baseline and treatment.

    Time frame: Baseline, Week 12

07

Results

Posted Apr 24, 2018

Participant flow

Participant flow — Overall Study
MilestonePlacebo10 mg LY240902130 mg LY240902160 mg LY2409021
Started10173426
≥1 post baseline value by assigned group9173425
Received at least 1 dose of study drug9173425
Completed8113019
Not completed2647
Withdrew: Adverse event0203
Withdrew: Investigator decision0101
Withdrew: Lost to follow-up0101
Withdrew: Protocol violation0011
Withdrew: Sponsor decision1000
Withdrew: Withdrawal by subject1231

Outcome measures

PrimaryMean Change in Glycosylated Hemoglobin A1c (HbA1c)

HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. Least Squares (LS) mean was calculated using a mixed-model repeated measures analysis (MMRM) that included terms for treatment group, baseline HbA1c, metformin use, visit, and visit-by-treatment interaction.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · percentage of HbA1c
Mean Change in Glycosylated Hemoglobin A1c (HbA1c)
percentage of HbA1cPlacebo10 mg LY240902130 mg LY240902160 mg LY2409021
Mean Change in Glycosylated Hemoglobin A1c (HbA1c)0.11 (-0.44 to 0.65)-0.83 (-1.28 to -0.38)-0.65 (-0.93 to -0.37)-0.66 (-1.00 to -0.31)
Statistical analysis
  • Placebo vs 10 mg LY2409021 · Mixed Models Analysis · p = 0.0296 · Mean difference (final values): -0.94 · 90% CI -1.64 to -0.23
  • Placebo vs 30 mg LY2409021 · Mixed Models Analysis · p = 0.0418 · Mean difference (final values): -0.76 · 90% CI -1.37 to -0.15
  • Placebo vs 60 mg LY2409021 · Mixed Models Analysis · p = 0.0514 · Mean difference (final values): -0.76 · 90% CI -1.41 to -0.12
SecondaryChange From Baseline Values for Fasting Blood Glucose (FBG)

LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · millimoles/liter (mmol/L)
Change From Baseline Values for Fasting Blood Glucose (FBG)
millimoles/liter (mmol/L)Placebo10 mg LY240902130 mg LY240902160 mg LY2409021
Change From Baseline Values for Fasting Blood Glucose (FBG)1.19 (-0.93 to 3.32)-0.43 (-2.30 to 1.44)-0.67 (-1.76 to 0.42)-1.22 (-2.55 to 0.11)
Statistical analysis
  • Placebo vs 10 mg LY2409021 · Mixed Models Analysis · p = 0.2565 · Mean difference (final values): -1.62 · 95% CI -4.46 to 1.21
  • Placebo vs 30 mg LY2409021 · Mixed Models Analysis · p = 0.1245 · Mean difference (final values): -1.86 · 95% CI -4.25 to 0.53
  • Placebo vs 60 mg LY2409021 · Mixed Models Analysis · p = 0.0594 · Mean difference (final values): -2.41 · 95% CI -4.92 to 0.10
SecondaryChange From Baseline for Glucose Area Under the Curve (AUC) From Oral Glucose Tolerance Test (OGTT)

LS mean was calculated using analysis of covariance (ANCOVA) model that included terms for treatment group, baseline value and metformin use.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · mmol/L
Change From Baseline for Glucose Area Under the Curve (AUC) From Oral Glucose Tolerance Test (OGTT)
mmol/LPlacebo10 mg LY240902130 mg LY240902160 mg LY2409021
Change From Baseline for Glucose Area Under the Curve (AUC) From Oral Glucose Tolerance Test (OGTT)172.89 (-117.67 to 463.46)48.34 (-178.20 to 274.88)-165.74 (-297.35 to -34.14)-293.94 (-458.59 to -129.29)
Statistical analysis
  • Placebo vs 10 mg LY2409021 · ANCOVA · p = 0.4978 · Mean difference (final values): -124.56 · 95% CI -490.02 to 240.90
  • Placebo vs 30 mg LY2409021 · ANCOVA · p = 0.0372 · Mean difference (final values): -338.64 · 95% CI -656.55 to -20.72
  • Placebo vs 60 mg LY2409021 · ANCOVA · p = 0.0068 · Mean difference (final values): -466.83 · 95% CI -799.48 to -134.18
SecondaryChange From Baseline to Endpoint for Fasting Triglycerides

LS mean was calculated using ANCOVA model that included terms for treatment group, baseline value and metformin use.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · mmol/L
Change From Baseline to Endpoint for Fasting Triglycerides
mmol/LPlacebo10 mg LY240902130 mg LY240902160 mg LY2409021
Change From Baseline to Endpoint for Fasting Triglycerides0.1 ± 0.240.2 ± 0.200.2 ± 0.120 ± 0.14
Statistical analysis
  • Placebo vs 10 mg LY2409021 · ANCOVA · p = 0.814 · Mean difference (final values): 0.1 · 95% CI -0.5 to 0.7
  • Placebo vs 30 mg LY2409021 · ANCOVA · p = 0.681 · Mean difference (final values): 0.1 · 95% CI -0.4 to 0.7
  • Placebo vs 60 mg LY2409021 · ANCOVA · p = 0.715 · Mean difference (final values): -0.1 · 95% CI -0.7 to 0.5
SecondaryTotal and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R)

The DSC-R was a participant completed questionnaire that was designed to assess the presence and perceived burden of diabetes-related symptoms. Participants were asked to recall the last 4 weeks and consider each symptom/item in terms of whether they experienced it and if so, how troublesomeness it was. Participants were to consider troublesomeness of the symptom on a 1 (not at all) to 5 (extremely) point scale. There were a total of 34 items, grouped into 8 subscales: cardiovascular (4 items), psychological-cognitive distress (4 items), psychological-fatigue (4 items), hyperglycemic (4 items), hypoglycemic (3 items), neurological-pain (4 items), neurological-sensory (6 items) and visual (5 items). Sub-domain score calculated as: (sum of item scores) divided by (number of items), scores ranged from 1 to 5. Total score was the sum of all sub-domains and ranged from 8 to 40. Higher scores of total and subscales indicated worsened symptoms.

Time frame:
Baseline, Week 12
Reported as:
Mean · units on a scale
Total and Sub-Domain Scores of Diabetes Symptom Checklist-Revised (DSC-R)
units on a scalePlacebo10 mg LY240902130 mg LY240902160 mg LY2409021
Cardiovascular2.5 ± NA1.52 ± 0.3721.52 ± 0.4751.69 ± 0.586
Hyperglycemic3.18 ± 1.5172.79 ± 1.0862.30 ± 0.4372.37 ± 0.563
Hypoglycemic1.50 ± 07072.42 ± 1.2582.50 ± 0.9802.00 ± 1.277
Neurological-Pain2.00 ± NA1.91 ± 0.7171.88 ± 0.3961.80 ± 0636
Neurological-Sensory2.39 ± 0.4381.89 ± 0.5872.35 ± 0.5962.11 ± 0.893
Visual1.00 ± NA2.45 ± 1.1722.03 ± 0.8122.05 ± 1.160
Psychological-Cognitive1.61 ± 0.8602.31 ± 0.8752.37 ± 0.9671.69 ± 0.636
Psychological-Fatigue1.91 ± 0.2192.06 ± 0.7342.33 ± 0.5842.07 ± 0.500
TotalNA ± NANA ± NANA ± NANA ± NA
SecondaryChange From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021)

The Diabetes Medicines Survey was a participant reported questionnaire consisting of 25 items: perceived effectiveness of diabetes medicines (items 1-10) and physical side-effects (items 11-25). Both domains had a scores range from 1 (all of the time) to 4 (none of the time) and a possible total scores range from 25 to 100. Lower scores for perceived effectiveness items indicated a better perceived effectiveness. Lower scores for physical side-effects items indicated a greater frequency of physical side-effects.

Time frame:
Baseline, Week 12
Reported as:
Mean · units on a scale
Change From Baseline in the Diabetes Medicines Survey Perceived Effectiveness and Physical Side-Effects (Differences Between Perceptions About Medication-Diabetes Scores Between Placebo and LY2409021)
units on a scalePlacebo10 mg LY240902130 mg LY240902160 mg LY2409021
Medication controlling blood sugar(BS)1.75 ± 0.8862.00 ± 0.8941.77 ± 0.6791.53 ± 0.697
Meeting medical needs1.75 ± 0.8862.09 ± 0.8311.80 ± 0.8051.58 ± 0.769
Medication working well1.75 ± 0.8862.00 ± 0.8941.70 ± 0.7941.63 ± 0.831
Medication giving good results1.88 ± 0.8352.00 ± 0.8941.87 ± 0.7761.58 ± 0692
Medication making me feel better2.00 ± 1.0692.09 ± 0.8311.90 ± 0.7121.84 ± 0.688
Medication taking care of illness2.00 ± 1.0692.09 ± 0.8311.83 ± 0.8341.58 ± 0.692
Medication therapy is failing3.63 ± 0.7443.18 ± 0.8743.17 ± 0.9283.58 ± 0769
Medication giving 24-hour control2.13 ± 1.1262.27 ± 1.1042.03 ± 0.8231.68 ± 0.671
Medication therapy is effective1.88 ± 0.8352.09 ± 0.9441.87 ± 0.7301.74 ± 0.733
Medication keeping BS stable2.00 ± 0.9262.18 ± 0.9821.97 ± 0.7181.68 ± 0.671
Side Effect: Constipation3.88 ± 0.3543.18 ± 1.1683.83 ± 0.3793.63 ± 0.761
Side Effect: Feet or hands swelling3.75 ± 0.4633.91 ± 0.3023.80 ± 0.4073.84 ± 0.375
Side Effect: Headaches3.63 ± 0.5183.45 ± 0.6883.60 ± 05633.79 ± 0.419
Side Effect: Weight gain3.63 ± 0.5183.73 ± 0.4673.57 ± 0.7283.79 ± 0.419
Side Effect: Dizziness/Lightheaded3.75 ± 0.4633.73 ± 0.4673.90 ± 0.4033.89 ± 0.315
Side Effect: Muscle Cramps3.88 ± 0.3543.64 ± 0.8093.87 ± 0.3463.58 ± 0.769
Side Effect: Bloating3.63 ± 0.5183.82 ± 0.4053.83 ± 0.3793.79 ± 0.419
Side Effect: Diarrhea3.38 ± 0.7443.73 ± 0.4673.70 ± 0.5963.74 ± 0.452
Side Effect: Heartburn3.75 ± 0.4633.73 ± 0.6473.72 ± 0.5283.79 ± 0.535
Side Effect: Excessive Sweating3.75 ± 0.4633.64 ± 0.8093.77 ± 0.5683.79 ± 0.535
Side Effect: Itching3.88 ± 0.3543.73 ± 0.4673.90 ± 0.4033.84 ± 0.501
Side Effect: Hypoglycemia4.00 ± 0.0003.82 ± 0.4053.90 ± 0.3053.89 ± 0.315
Side Effect: Stomach Pain3.75 ± 0.7073.73 ± 0.6473.93 ± 0.2543.84 ± 0.375
Side Effect: Upset Stomach3.63 ± 0.7444.00 ± 0.0003.90 ± 0.3053.79 ± 0.535
Side Effect: Muscle Soreness3.75 ± 0.4633.82 ± 0.6033.77 ± 0.5043.63 ± 0.597
SecondaryChange From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles

Participants obtained 7-point SMBG values immediately before and 2 hours after each meal and at bedtime. LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · milligrams/deciliter (mg/dL)
Change From Baseline Values for 7-Point Self-Monitored Blood Glucose (SMBG) Profiles
milligrams/deciliter (mg/dL)Placebo10 mg LY240902130 mg LY240902160 mg LY2409021
Pre-Morning Meal Fasting13.46 (-2.23 to 29.15)-10.09 (-23.27 to 3.08)-21.82 (-30.19 to -13.44)-25.86 (-36.20 to -15.52)
2 Hours After Morning Meal-27.48 (-49.06 to -5.90)-33.90 (-52.13 to -15.67)-35.68 (-46.98 to -24.38)-34.68 (-48.61 to -20.75)
Pre Mid-Day Meal16.43 (-2.08 to 34.94)-19.39 (-35.07 to -3.71)-16.72 (-26.55 to -6.90)-21.44 (-33.55 to -9.33)
2 Hours After Mid-Day Meal-6.86 (-27.59 to 13.88)-35.34 (-52.73 to -17.94)-22.51 (-33.57 to -11.46)-29.42 (-42.91 to -15.92)
Pre Evening Meal28.16 (5.23 to 51.08)-16.62 (-36.01 to 2.77)-26.29 (-38.48 to -14.11)-18.03 (-33.00 to -3.07)
2 Hours After Evening Meal12.02 (-11.55 to 35.58)-27.80 (-47.30 to -8.31)-31.78 (-44.13 to -19.42)-27.54 (-42.73 to -12.34)
Bedtime17.19 (-5.34 to 39.72)-19.69 (-38.75 to -0.63)-29.31 (-41.14 to -17.48)-24.88 (-39.84 to -9.92)
Statistical analysis
  • Placebo vs 10 mg LY2409021 · Mixed Models Analysis · p = 0.0248 (P-value is for Pre-Morning Meal (fasting).) · Mean difference (final values): -23.56 · 95% CI -44.03 to -3.09
  • Placebo vs 30 mg LY2409021 · Mixed Models Analysis · p = 0.0002 (P-value is for Pre-Morning Meal (fasting).) · Mean difference (final values): -35.28 · 95% CI -53.08 to -17.48
  • Placebo vs 60 mg LY2409021 · Mixed Models Analysis · p = <0.0001 (P-value is for Pre-Morning Meal (fasting).) · Mean difference (final values): -39.32 · 95% CI -58.12 to -20.53
  • Placebo vs 10 mg LY2409021 · Mixed Models Analysis · p = 0.6513 (P-value is for 2 Hours After Morning Meal.) · Mean difference (final values): -6.42 · 95% CI -34.66 to 21.82
  • Placebo vs 30 mg LY2409021 · Mixed Models Analysis · p = 0.5045 (P-value is for 2 Hours After Morning Meal.) · Mean difference (final values): -8.20 · 95% CI -32.61 to 16.21
  • Placebo vs 60 mg LY2409021 · Mixed Models Analysis · p = 0.5774 (P-value is for 2 Hours After Morning Meal.) · Mean difference (final values): -7.20 · 95% CI -32.90 to 18.49
  • Placebo vs 10 mg LY2409021 · Mixed Models Analysis · p = 0.0045 (P-value is for Pre-Mid-Day Meal.) · Mean difference (final values): -35.81 · 95% CI -60.10 to -11.53
  • Placebo vs 30 mg LY2409021 · Mixed Models Analysis · p = 0.0024 (P-value is for Pre-Mid-Day Meal.) · Mean difference (final values): -33.15 · 95% CI -54.10 to -12.21
  • Placebo vs 60 mg LY2409021 · Mixed Models Analysis · p = 0.0011 (P-value is for Pre-Mid-Day Meal.) · Mean difference (final values): -37.87 · 95% CI -59.98 to -15.75
  • Placebo vs 10 mg LY2409021 · Mixed Models Analysis · p = 0.0389 (P-value is for 2 Hours After Mid-Day Meal.) · Mean difference (final values): -28.48 · 95% CI -55.47 to -1.49
  • Placebo vs 30 mg LY2409021 · Mixed Models Analysis · p = 0.1896 (P-value is for 2 Hours After Mid-Day Meal.) · Mean difference (final values): -15.65 · 95% CI -39.24 to 7.94
  • Placebo vs 60 mg LY2409021 · Mixed Models Analysis · p = 0.0729 (P-value is for 2 Hours After Mid-Day Meal.) · Mean difference (final values): -22.56 · 95% CI -47.28 to 2.16
  • Placebo vs 10 mg LY2409021 · Mixed Models Analysis · p = 0.0041 (P-value is for Pre Evening Meal.) · Mean difference (final values): -44.78 · 95% CI -74.79 to -14.77
  • Placebo vs 30 mg LY2409021 · Mixed Models Analysis · p = <0.0001 (P-value is for Pre Evening Meal.) · Mean difference (final values): -54.45 · 95% CI -80.42 to -28.48
  • Placebo vs 60 mg LY2409021 · Mixed Models Analysis · p = 0.0013 (P-value is for Pre Evening Meal.) · Mean difference (final values): -46.19 · 95% CI -73.57 to -18.81
  • Placebo vs 10 mg LY2409021 · Mixed Models Analysis · p = 0.0118 (P-value is for 2 Hours After Evening Meal.) · Mean difference (final values): -39.82 · 95% CI -70.51 to -9.13
  • Placebo vs 30 mg LY2409021 · Mixed Models Analysis · p = 0.0016 (P-value is for 2 Hours After Evening Meal.) · Mean difference (final values): -43.80 · 95% CI -70.42 to -17.18
  • Placebo vs 60 mg LY2409021 · Mixed Models Analysis · p = 0.0065 (P-value is for 2 Hours After Evening Meal.) · Mean difference (final values): -39.56 · 95% CI -67.63 to -11.48
  • Placebo vs 10 mg LY2409021 · Mixed Models Analysis · p = 0.0154 (P-value is for Bedtime.) · Mean difference (final values): -36.88 · 95% CI -66.43 to -7.33
  • Placebo vs 30 mg LY2409021 · Mixed Models Analysis · p = 0.0006 (P-value is for Bedtime.) · Mean difference (final values): -46.50 · 95% CI -71.93 to -21.07
  • Placebo vs 60 mg LY2409021 · Mixed Models Analysis · p = 0.0029 (P-value is for Bedtime.) · Mean difference (final values): -42.07 · 95% CI -69.13 to -15.01
SecondaryChange From Baseline Values for Fasting Insulin

LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · picomole/liter (pmol/L)
Change From Baseline Values for Fasting Insulin
picomole/liter (pmol/L)Placebo10 mg LY240902130 mg LY240902160 mg LY2409021
Change From Baseline Values for Fasting Insulin-10.91 (-56.58 to 34.76)14.71 (-21.17 to 50.59)-5.51 (-27.50 to 16.49)13.34 (-14.08 to 40.76)
Statistical analysis
  • Placebo vs 10 mg LY2409021 · Mixed Models Analysis · p = 0.3815 · Mean difference (final values): 25.62 · 95% CI -32.44 to 83.68
  • Placebo vs 30 mg LY2409021 · Mixed Models Analysis · p = 0.8315 · Mean difference (final values): 5.40 · 95% CI -45.12 to 55.93
  • Placebo vs 60 mg LY2409021 · Mixed Models Analysis · p = 0.3658 · Mean difference (final values): 24.25 · 95% CI -28.93 to 77.44
SecondaryChange From Baseline Values for Fasting Glucagon

LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · pmol/L
Change From Baseline Values for Fasting Glucagon
pmol/LPlacebo10 mg LY240902130 mg LY240902160 mg LY2409021
Change From Baseline Values for Fasting Glucagon-2.36 (-70.57 to 65.85)52.71 (-1.84 to 107.25)87.32 (52.35 to 122.30)104.90 (61.28 to 148.52)
Statistical analysis
  • Placebo vs 10 mg LY2409021 · Mixed Models Analysis · p = 0.2131 · Mean difference (final values): 55.06 · 95% CI -32.24 to 142.37
  • Placebo vs 30 mg LY2409021 · Mixed Models Analysis · p = 0.0220 · Mean difference (final values): 89.68 · 95% CI 13.27 to 166.10
  • Placebo vs 60 mg LY2409021 · Mixed Models Analysis · p = 0.0101 · Mean difference (final values): 107.26 · 95% CI 26.29 to 188.22
SecondaryChange From Baseline Values for Fasting Glucagon-Like Peptide 1 (GLP-1)

LS mean was calculated using a MMRM that included terms for treatment group, baseline value, metformin use, visit, and visit-by-treatment interaction.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · pmol/L
Change From Baseline Values for Fasting Glucagon-Like Peptide 1 (GLP-1)
pmol/LPlacebo10 mg LY240902130 mg LY240902160 mg LY2409021
Change From Baseline Values for Fasting Glucagon-Like Peptide 1 (GLP-1)-1.43 (-3.44 to 0.58)0.44 (-1.24 to 2.13)0.61 (-0.45 to 1.66)0.28 (-1.00 to 1.57)
Statistical analysis
  • Placebo vs 10 mg LY2409021 · Mixed Models Analysis · p = 0.1596 · Mean difference (final values): 1.87 · 95% CI -0.75 to 4.49
  • Placebo vs 30 mg LY2409021 · Mixed Models Analysis · p = 0.0791 · Mean difference (final values): 2.03 · 95% CI -0.24 to 4.31
  • Placebo vs 60 mg LY2409021 · Mixed Models Analysis · p = 0.1564 · Mean difference (final values): 1.71 · 95% CI -0.67 to 4.10
SecondaryChange From Baseline for Insulin AUC From OGTT

LS mean was calculated using an ANCOVA that included terms for treatment group, baseline value and metformin use.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · pmol/L
Change From Baseline for Insulin AUC From OGTT
pmol/LPlacebo10 mg LY240902130 mg LY240902160 mg LY2409021
Change From Baseline for Insulin AUC From OGTT2357.88 (-14350.13 to 19065.88)10376.38 (-2525.67 to 23278.44)7532.72 (-199.74 to 15265.19)20511.79 (10583.81 to 30439.77)
Statistical analysis
  • Placebo vs 10 mg LY2409021 · ANCOVA · p = 0.4500 · Mean difference (final values): 8018.51 · 95% CI -13104.14 to 29141.16
  • Placebo vs 30 mg LY2409021 · ANCOVA · p = 0.5739 · Mean difference (final values): 5174.85 · 95% CI -13158.65 to 23508.35
  • Placebo vs 60 mg LY2409021 · ANCOVA · p = 0.0653 · Mean difference (final values): 18153.92 · 95% CI -1188.23 to 37496.06
SecondaryChange From Baseline for C-Peptide AUC From OGTT

LS mean was calculated using an ANCOVA model that included terms for treatment group, baseline value and metformin use.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · pmol/L
Change From Baseline for C-Peptide AUC From OGTT
pmol/LPlacebo10 mg LY240902130 mg LY240902160 mg LY2409021
Change From Baseline for C-Peptide AUC From OGTT20380.84 (-38421.86 to 79183.54)38475.16 (-4765.49 to 81715.81)26164.43 (-535.64 to 52864.50)56599.82 (23333.38 to 89866.26)
Statistical analysis
  • Placebo vs 10 mg LY2409021 · ANCOVA · p = 0.6209 · Mean difference (final values): 18094.32 · 95% CI -54734.08 to 90922.71
  • Placebo vs 30 mg LY2409021 · ANCOVA · p = 0.8581 · Mean difference (final values): 5783.59 · 95% CI -58650.71 to 70217.89
  • Placebo vs 60 mg LY2409021 · ANCOVA · p = 0.2850 · Mean difference (final values): 36218.98 · 95% CI -30955.50 to 103393.46
SecondaryChange From Baseline to Endpoint for Low Density Lipoprotein (LDL)

Fasting LDL LS mean was calculated using ANCOVA that included terms for baseline and treatment.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · mmol/L
Change From Baseline to Endpoint for Low Density Lipoprotein (LDL)
mmol/LPlacebo10 mg LY240902130 mg LY240902160 mg LY2409021
Change From Baseline to Endpoint for Low Density Lipoprotein (LDL)0.4 ± 0.210.3 ± 0.150.2 ± 0.110.3 ± 0.13
Statistical analysis
  • Placebo vs 10 mg LY2409021 · ANCOVA · p = 0.584 · Mean difference (final values): -0.1 · 95% CI -0.7 to 0.4
  • Placebo vs 30 mg LY2409021 · ANCOVA · p = 0.426 · Mean difference (final values): -0.2 · 95% CI -0.7 to 0.3
  • Placebo vs 60 mg LY2409021 · ANCOVA · p = 0.657 · Mean difference (final values): -0.1 · 95% CI -0.6 to 0.4
SecondaryChange From Baseline to Endpoint for High Density Lipoprotein (HDL)

Fasting HDL LS mean was calculated using ANCOVA that included terms for baseline and treatment.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · mmol/L
Change From Baseline to Endpoint for High Density Lipoprotein (HDL)
mmol/LPlacebo10 mg LY240902130 mg LY240902160 mg LY2409021
Change From Baseline to Endpoint for High Density Lipoprotein (HDL)-0.1 ± 0.110 ± 0.070.1 ± 0.050 ± 0.06
Statistical analysis
  • Placebo vs 10 mg LY2409021 · ANCOVA · p = 0.365 · Mean difference (final values): 0.1 · 95% CI -0.1 to 0.4
  • Placebo vs 30 mg LY2409021 · ANCOVA · p = 0.191 · Mean difference (final values): 0.2 · 95% CI -0.1 to 0.4
  • Placebo vs 60 mg LY2409021 · ANCOVA · p = 0.297 · Mean difference (final values): 0.1 · 95% CI -0.1 to 0.4
SecondaryChange From Baseline to Endpoint for Non-HDL Cholesterol

Fasting non-HDL cholesterol LS mean was calculated using ANCOVA that included terms for baseline and treatment.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · mmol/L
Change From Baseline to Endpoint for Non-HDL Cholesterol
mmol/LPlacebo10 mg LY240902130 mg LY240902160 mg LY2409021
Change From Baseline to Endpoint for Non-HDL Cholesterol0.5 ± 0.240.3 ± 0.170.3 ± 0.120.3 ± 0.14
Statistical analysis
  • Placebo vs 10 mg LY2409021 · ANCOVA · p = 0.523 · Mean difference (final values): -0.2 · 95% CI -0.8 to 0.4
  • Placebo vs 30 mg LY2409021 · ANCOVA · p = 0.476 · Mean difference (final values): -0.2 · 95% CI -0.7 to 0.3
  • Placebo vs 60 mg LY2409021 · ANCOVA · p = 0.634 · Mean difference (final values): -0.1 · 95% CI -0.7 to 0.4
SecondaryChange From Baseline to Endpoint for Total Cholesterol

Fasting total cholesterol LS mean was calculated using ANCOVA that included terms for baseline and treatment.

Time frame:
Baseline, Week 12
Reported as:
Least squares mean · mmol/L
Change From Baseline to Endpoint for Total Cholesterol
mmol/LPlacebo10 mg LY240902130 mg LY240902160 mg LY2409021
Change From Baseline to Endpoint for Total Cholesterol0.3 ± 0.240.3 ± 0.180.3 ± 0.120.4 ± 0.15
Statistical analysis
  • Placebo vs 10 mg LY2409021 · ANCOVA · p = 0.919 · Mean difference (final values): 0.0 · 95% CI -0.6 to 0.6
  • Placebo vs 30 mg LY2409021 · ANCOVA · p = 0.864 · Mean difference (final values): 0.0 · 95% CI -0.5 to 0.6
  • Placebo vs 60 mg LY2409021 · ANCOVA · p = 0.726 · Mean difference (final values): 0.1 · 95% CI -0.5 to 0.7

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo—0/9 (0%)6/9 (66.7%)
10 mg LY2409021—1/17 (5.9%)14/17 (82.4%)
30 mg LY2409021—0/34 (0%)25/34 (73.5%)
60 mg LY2409021—1/25 (4%)18/25 (72%)
Most frequent serious events
Most frequent serious events
EventPlacebo10 mg LY240902130 mg LY240902160 mg LY2409021
Alanine aminotransferase increasedInvestigations0/91/170/340/25
Aspartate aminotransferase increasedInvestigations0/91/170/340/25
Gamma-glutamyltransferase increasedInvestigations0/91/170/340/25
CellulitisInfections and infestations0/90/170/341/25
Most frequent other events
Showing 10 of 45
Most frequent other events
EventPlacebo10 mg LY240902130 mg LY240902160 mg LY2409021
NauseaGastrointestinal disorders2/91/175/342/25
HypoglycaemiaMetabolism and nutrition disorders0/93/172/344/25
Back painMusculoskeletal and connective tissue disorders0/93/170/342/25
DizzinessNervous system disorders0/93/172/340/25
DiarrhoeaGastrointestinal disorders1/92/172/344/25
Pharyngolaryngeal painRespiratory, thoracic and mediastinal disorders1/90/175/341/25
FatigueGeneral disorders0/91/173/343/25
HeadacheNervous system disorders1/91/172/343/25
ConstipationGastrointestinal disorders0/91/174/341/25
BronchitisInfections and infestations0/92/170/340/25

Baseline characteristics

All randomized participants.

Age, Continuous
Age, Continuous(years)Placebo10 mg LY240902130 mg LY240902160 mg LY2409021Total
Mean50.8 ± 4.9253.3 ± 10.2052.0 ± 10.8852.5 ± 6.4152.3 ± 8.93
Sex: Female, Male
Sex: Female, Male(Participants)Placebo10 mg LY240902130 mg LY240902160 mg LY2409021Total
Female56181847
Male51116840
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Placebo10 mg LY240902130 mg LY240902160 mg LY2409021Total
Hispanic or Latino710151648
Not Hispanic or Latino37191039
Unknown or Not Reported00000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Placebo10 mg LY240902130 mg LY240902160 mg LY2409021Total
American Indian or Alaska Native149923
Asian02136
Native Hawaiian or Other Pacific Islander00000
Black or African American435315
White57181141
More than one race01001
Unknown or Not Reported00101
Region of Enrollment
Region of Enrollment(Participants)Placebo10 mg LY240902130 mg LY240902160 mg LY2409021Total
United States1017342687
08

Study locations

19 sites
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Buena Park, California 90620, United States
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    Huntington Park, California 90255, United States
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    Westlake Village, California 91361, United States
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    Fort Lauderdale, Florida 33306, United States
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    Jupiter, Florida 33458, United States
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    New Port Richey, Florida 34652, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Idaho Falls, Idaho 83404, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Topeka, Kansas 66606, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Madisonville, Kentucky 42431, United States
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    Las Vegas, Nevada 89101, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Rapid City, South Dakota 57702, United States
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    San Antonio, Texas 78229, United States
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    Norfolk, Virginia 23502, United States
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    Aschaffenburg, 63739, Germany
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Mainz, 55116, Germany
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Munchen, 80336, Germany
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    Saarlouis, 66740, Germany
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    Kaunas, LT-51270, Lithuania
  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    Vilnius, LT-08661, Lithuania
09

References and documents

Publications

  • Kazda CM, Ding Y, Kelly RP, Garhyan P, Shi C, Lim CN, Fu H, Watson DE, Lewin AJ, Landschulz WH, Deeg MA, Moller DE, Hardy TA. Evaluation of Efficacy and Safety of the Glucagon Receptor Antagonist LY2409021 in Patients With Type 2 Diabetes: 12- and 24-Week Phase 2 Studies. Diabetes Care. 2016 Jul;39(7):1241-9. doi: 10.2337/dc15-1643. Epub 2015 Dec 17. Erratum In: Diabetes Care. 2017 Jun;40(6):808. doi: 10.2337/dc17-er06. PubMed 26681715 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00871572
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Mar 30, 2009
Start date
Mar 2009
Primary completion
Feb 2010
Completion
Feb 2010
Results posted
Apr 24, 2018
Last update
Apr 24, 2018

Study contacts

Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5 PM Eastern time (UTC/GMT - 5 hours, EST)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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