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CompletedNCT02059187Updated Sep 6, 2018Results posted

The Safety and Efficacy of MK-1293 Versus Lantus™ in Participants With Type 2 Diabetes Mellitus (MK-1293-006)

A Phase 3 interventional study of MK-1293 and Lantus™ in Type 2 Diabetes Mellitus, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-06.

Sponsored by Merck Sharp & Dohme LLC · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
531
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This 24-week study is a safety and efficacy comparison of MK-1293 and Lantus™ in participants with type 2 diabetes mellitus (T2DM). The primary hypothesis is that after 24 weeks, the mean change in hemoglobin A1c (A1C) from baseline is non-inferior (with margin of 0.4%) in participants treated with MK-1293 compared with that in participants treated with Lantus™.

02

Conditions studied

  • Type 2 Diabetes Mellitus
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 531 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosis of Type 2 Diabetes Mellitus (T2DM) as defined by the American Diabetes Association (ADA) or the European Association for the Study of Diabetes (EASD)
  • hemoglobin A1C of ≤11.0% and requires insulin for glycemic control
  • Body mass index (BMI) \<45 kg/m\^2

Exclusion criteria

Exclusion Criteria:

  • History of type 1 diabetes mellitus or a history of ketoacidosis, or has type 1 diabetes confirmed with a C-peptide \<0.7 ng/mL (0.23 nmol/L)
  • One or more severe hypoglycemic episodes associated with hypoglycemic seizures, comas or unconsciousness within the past 6 months
  • History of intolerance or hypersensitivity to Lantus™ or contraindication to Lantus™ or one of its excipients based on the label of the country of the investigational site
  • On a weight loss program within the last 8 weeks
  • Received injectable incretin-based therapy (e.g., Victoza™, Byetta™) within the prior 8 weeks
  • Bariatric surgery within 12 months prior to signing the informed consent
  • Likely to require treatment for ≥2 consecutive weeks or repeated courses of corticosteroids
  • Undergone a surgical procedure within 4 weeks prior to signing informed consent or has planned major surgery during the study
  • New or worsening signs or symptoms of coronary heart disease or congestive heart failure within the last 3 months
  • Presence of any of the following during the last 3 months: acute coronary syndrome, coronary artery intervention, and/or stroke or transient ischemic neurological disorder
  • Severe peripheral vascular disease
  • Systolic blood pressure ≥ 160 mm Hg or a diastolic ≥95 mm Hg and blood pressure is not considered likely to be under these limits with an adjustment in antihypertensive medication
  • Chronic myopathy or a progressive neurological or neuromuscular disorder
  • Active nephropathy
  • History of active liver disease (other than non-alcoholic hepatic steatosis), including chronic active hepatitis B or C, primary biliary cirrhosis, or symptomatic gallbladder disease
  • Human immunodeficiency virus (HIV)
  • Clinically important hematological disorder (such as aplastic anemia, myeloproliferative or myelodysplastic syndromes, thrombocytopenia)
  • History of malignancy ≤5 years prior to signing informed consent, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
  • History of melanoma, leukemia, lymphoma, or renal cell carcinoma
  • Hyperthyroidism
  • On a stable dose of thyroid hormone replacement therapy for \<6 weeks
  • Uses recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence
  • Pregnant or breast-feeding, or is expecting to conceive or donate eggs during the study, including 14 days following the last dose of study drug
  • Donated blood products or has had phlebotomy of >300 mL within 8 weeks of signing informed consent, or intends to donate blood products within the projected duration of the study
  • Poor mental function or any other reason to expect that the participant may have difficulty in complying with the requirements of the study
  • Clinically significant ECG abnormality which exposes the participant to risk by enrolling in the study
  • Positive urine pregnancy test
  • Participant is a night shift worker which causes difficulty complying with the overnight fast requirement and has potential for confounding the 7-point SMBG analysis
  • Participant, as assessed by the investigator, is not appropriate for or does not agree to target a fasting glucose of 70-100 mg/dL [3.9 -5.6 mmol/L]
  • Has used a formulation of glargine insulin other than Lantus™
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
531 participants (actual)

Study arms

  • Experimental
    MK-1293

    MK-1293 administered subcutaneously once daily in the evening.

    Drug: MK-1293 · Drug: Prandial insulin

  • Active comparator
    Lantus™

    Lantus™ administered subcutaneously once daily in the evening.

    Drug: Lantus™ · Drug: Prandial insulin

Interventions

  • DrugMK-1293

    MK-1293 (insulin glargine) 100 units/mL administered subcutaneously once daily for 24 weeks. Participants not taking insulin at study entry will initiate MK-1293 at 10 units daily. Participants taking insulin will initiate MK-1293 at an appropriate dose based on prior insulin dosing. After initiation, the dose will be titrated to the suggested target for fasting finger stick glucose. MK-1293 dosing once daily at times other than bedtime will be permitted for participants with a previously established dosing time.

  • DrugLantus™

    Lantus™ (insulin glargine \[rDNA origin\]) 100 units/mL administered subcutaneously once daily for 24 weeks. Participants not taking insulin at study entry will initiate Lantus™ at 10 units daily. Participants taking insulin will initiate Lantus™ at an appropriate dose based on prior insulin dosing. After initiation, the dose will be titrated to the suggested target for fasting finger stick glucose. Lantus™ dosing once daily at times other than bedtime will be permitted for participants with a previously established dosing time.

    Also known as: Insulin glargine [rDNA origin]

  • DrugPrandial insulin

    Participants taking prandial insulin will continue their current prandial insulin regimen during the insulin glargine titration. After the insulin glargine titration phase, the prandial insulin may be adjusted if the investigator determines it to be necessary for glucose control.

06

What researchers measure

Primary outcomes

  1. Change From Baseline in Participant Hemoglobin A1C Level at Week 24

    A1C is measured as a percent. A1C is the key glycemic parameter which correlates with reduction of risk of diabetic complications.

    Time frame: Baseline and Week 24

  2. Percentage of Participants With Confirmed Anti-Insulin Antibodies (AIA) up to Week 24

    Percentage of participants is a cumulative percentage of participants with any confirmed AIA (including baseline) up to Week 24.

    Time frame: Up to 24 weeks

Secondary outcomes

  1. Change From Baseline in Participant Body Weight at Week 24

    Change from baseline in participant body weight at Week 24.

    Time frame: Baseline and Week 24

  2. Percentage of Participants Experiencing an Adverse Event (AE) of Hypoglycemia Up to Week 24

    Symptomatic events assessed as likely to be hypoglycemia were to be reported by investigators as adverse events of hypoglycemia; a concurrent glucose measurement was not required. Asymptomatic events with confirmed glucose levels \</= 70mg/dL (\</= 3.9mmol/L) could also be reported as adverse events at the discretion of the investigator.

    Time frame: Up to 24 weeks

  3. Percentage of Participants Experiencing an AE Over the 24-week Treatment Period

    An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the investigational product, is also an AE.

    Time frame: Up to 24 weeks

  4. Daily Basal Insulin Dose (Units) at Week 24

    The daily basal insulin dose (measured in units) for any given visit is defined as the average dose from the three most recent days preceding the visit date.

    Time frame: Week 24

  5. Daily Basal Insulin Dose Per Body Weight (Units/kg) at Week 24

    Basal insulin dose per body weight was calculated as total insulin dose (units) per day divided by body weight in kilograms (kg).

    Time frame: Week 24

  6. Change From Baseline in Participant Fasting Plasma Glucose (FPG) at Week 24

    Participants fasted (no food or drink except water and non-antihyperglycemic non-study medications as prescribed) for at least 8 hours prior to all study visits.

    Time frame: Baseline and Week 24

  7. Change From Baseline in Participant 7-Point Average of Self-Monitored Blood Glucose (SMBG) at Week 24

    7-Point Average of SMBG was defined as the mean of blood glucose measurements taken at the following 7 times: before morning meal, after morning meal, before midday meal, after midday meal, before evening meal, after evening meal or at bedtime, and between 2 AM and 4 AM.

    Time frame: Baseline and Week 24

  8. Percentage of Participants With Hemoglobin A1C <7% at Week 24

    Percentage of participants with A1C \<7.0% (53 mmol/mol) at Week 24.

    Time frame: Week 24

  9. Percentage of Participants With Hemoglobin A1C <6.5% at Week 24

    Percentage of participants with A1C \<6.5% (48 mmol/mol) at Week 24.

    Time frame: Week 24

07

Results

Posted Mar 8, 2017

Participant flow

Participant flow — Overall Study
MilestoneMK-1293Lantus™
Started265266
Completed240244
Not completed2522
Withdrew: Adverse event03
Withdrew: Death11
Withdrew: Lost to follow-up98
Withdrew: Non-compliance with study drug10
Withdrew: Physician decision12
Withdrew: Protocol violation10
Withdrew: Withdrawal by subject128

Outcome measures

PrimaryChange From Baseline in Participant Hemoglobin A1C Level at Week 24

A1C is measured as a percent. A1C is the key glycemic parameter which correlates with reduction of risk of diabetic complications.

Time frame:
Baseline and Week 24
Reported as:
Least squares mean · Percent A1C
Change From Baseline in Participant Hemoglobin A1C Level at Week 24
Percent A1CMK-1293Lantus™
Change From Baseline in Participant Hemoglobin A1C Level at Week 24-1.28 (-1.41 to -1.15)-1.30 (-1.43 to -1.18)
Statistical analysis
  • MK-1293 vs Lantus™ · Difference in least squares means: 0.03 · 95% CI -0.12 to 0.18
PrimaryPercentage of Participants With Confirmed Anti-Insulin Antibodies (AIA) up to Week 24

Percentage of participants is a cumulative percentage of participants with any confirmed AIA (including baseline) up to Week 24.

Time frame:
Up to 24 weeks
Reported as:
Number · Percentage of participants
Percentage of Participants With Confirmed Anti-Insulin Antibodies (AIA) up to Week 24
Percentage of participantsMK-1293Lantus™
Percentage of Participants With Confirmed Anti-Insulin Antibodies (AIA) up to Week 2434.729.0
Statistical analysis
  • MK-1293 vs Lantus™ · Difference in percentage: 5.7 · 95% CI -2.3 to 13.7
SecondaryChange From Baseline in Participant Body Weight at Week 24

Change from baseline in participant body weight at Week 24.

Time frame:
Baseline and Week 24
Reported as:
Mean · kilograms
Change From Baseline in Participant Body Weight at Week 24
kilogramsMK-1293Lantus™
Change From Baseline in Participant Body Weight at Week 241.3 ± 3.61.4 ± 4.5
SecondaryPercentage of Participants Experiencing an Adverse Event (AE) of Hypoglycemia Up to Week 24

Symptomatic events assessed as likely to be hypoglycemia were to be reported by investigators as adverse events of hypoglycemia; a concurrent glucose measurement was not required. Asymptomatic events with confirmed glucose levels \</= 70mg/dL (\</= 3.9mmol/L) could also be reported as adverse events at the discretion of the investigator.

Time frame:
Up to 24 weeks
Reported as:
Number · Percentage of participants
Percentage of Participants Experiencing an Adverse Event (AE) of Hypoglycemia Up to Week 24
Percentage of participantsMK-1293Lantus™
Percentage of Participants Experiencing an Adverse Event (AE) of Hypoglycemia Up to Week 2454.054.0
Statistical analysis
  • MK-1293 vs Lantus™ · Difference in percentage: 0.0 · 95% CI -8.5 to 8.5
SecondaryPercentage of Participants Experiencing an AE Over the 24-week Treatment Period

An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the investigational product, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the investigational product, is also an AE.

Time frame:
Up to 24 weeks
Reported as:
Number · Percentage of participants
Percentage of Participants Experiencing an AE Over the 24-week Treatment Period
Percentage of participantsMK-1293Lantus™
Percentage of Participants Experiencing an AE Over the 24-week Treatment Period78.371.5
Statistical analysis
  • MK-1293 vs Lantus™ · Difference in percent: 6.8 · 95% CI -0.6 to 14.2
SecondaryDaily Basal Insulin Dose (Units) at Week 24

The daily basal insulin dose (measured in units) for any given visit is defined as the average dose from the three most recent days preceding the visit date.

Time frame:
Week 24
Reported as:
Least squares mean · Units
Daily Basal Insulin Dose (Units) at Week 24
UnitsMK-1293Lantus™
Daily Basal Insulin Dose (Units) at Week 2448.2 (44.9 to 51.5)46.9 (43.5 to 50.2)
Statistical analysis
  • MK-1293 vs Lantus™ · Difference in ls means: 1.4 · 95% CI -2.2 to 4.9
SecondaryDaily Basal Insulin Dose Per Body Weight (Units/kg) at Week 24

Basal insulin dose per body weight was calculated as total insulin dose (units) per day divided by body weight in kilograms (kg).

Time frame:
Week 24
Reported as:
Least squares mean · Units/kg
Daily Basal Insulin Dose Per Body Weight (Units/kg) at Week 24
Units/kgMK-1293Lantus™
Daily Basal Insulin Dose Per Body Weight (Units/kg) at Week 240.53 (0.49 to 0.56)0.51 (0.48 to 0.54)
Statistical analysis
  • MK-1293 vs Lantus™ · Dofference in ls means: 0.01 · 95% CI -0.02 to 0.05
SecondaryChange From Baseline in Participant Fasting Plasma Glucose (FPG) at Week 24

Participants fasted (no food or drink except water and non-antihyperglycemic non-study medications as prescribed) for at least 8 hours prior to all study visits.

Time frame:
Baseline and Week 24
Reported as:
Least squares mean · mg/dL
Change From Baseline in Participant Fasting Plasma Glucose (FPG) at Week 24
mg/dLMK-1293Lantus™
Change From Baseline in Participant Fasting Plasma Glucose (FPG) at Week 24-35.0 (-41.3 to -28.6)-38.4 (-44.8 to -32.1)
Statistical analysis
  • MK-1293 vs Lantus™ · Difference in ls means: 3.5 · 95% CI -3.7 to 10.7
SecondaryChange From Baseline in Participant 7-Point Average of Self-Monitored Blood Glucose (SMBG) at Week 24

7-Point Average of SMBG was defined as the mean of blood glucose measurements taken at the following 7 times: before morning meal, after morning meal, before midday meal, after midday meal, before evening meal, after evening meal or at bedtime, and between 2 AM and 4 AM.

Time frame:
Baseline and Week 24
Reported as:
Least squares mean · mg/dL
Change From Baseline in Participant 7-Point Average of Self-Monitored Blood Glucose (SMBG) at Week 24
mg/dLMK-1293Lantus™
Change From Baseline in Participant 7-Point Average of Self-Monitored Blood Glucose (SMBG) at Week 24-30.7 (-37.6 to -23.8)-27.3 (-34.0 to -20.5)
Statistical analysis
  • MK-1293 vs Lantus™ · Difference in ls means: -3.4 · 95% CI -11.3 to 4.4
SecondaryPercentage of Participants With Hemoglobin A1C <7% at Week 24

Percentage of participants with A1C \<7.0% (53 mmol/mol) at Week 24.

Time frame:
Week 24
Reported as:
Number · Percentage of participants
Percentage of Participants With Hemoglobin A1C <7% at Week 24
Percentage of participantsMK-1293Lantus™
Percentage of Participants With Hemoglobin A1C <7% at Week 2446.543.7
Statistical analysis
  • MK-1293 vs Lantus™ · Adjusted difference in percent: 2.8 · 95% CI -6.1 to 11.6Calculated via Miettinen and Nurminen method, stratified by prior insulin status.
SecondaryPercentage of Participants With Hemoglobin A1C <6.5% at Week 24

Percentage of participants with A1C \<6.5% (48 mmol/mol) at Week 24.

Time frame:
Week 24
Reported as:
Number · Percentage of participants
Percentage of Participants With Hemoglobin A1C <6.5% at Week 24
Percentage of participantsMK-1293Lantus™
Percentage of Participants With Hemoglobin A1C <6.5% at Week 2421.622.4
Statistical analysis
  • MK-1293 vs Lantus™ · Adjusted difference in percent: -0.9 · 95% CI -8.3 to 6.5Calculated via Miettinen and Nurminen method, stratified by prior insulin status.

Adverse events

Collected over Up to 26 weeks (including 2-week follow-up for serious adverse events). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
MK-1293—13/263 (4.9%)147/263 (55.9%)
Lantus™—9/263 (3.4%)151/263 (57.4%)
Most frequent serious events
Showing 10 of 39
Most frequent serious events
EventMK-1293Lantus™
Non-cardiac chest painGeneral disorders2/2631/263
Angina pectorisCardiac disorders0/2631/263
Angina unstableCardiac disorders1/2630/263
Cardiac failure congestiveCardiac disorders0/2631/263
Coronary artery diseaseCardiac disorders1/2630/263
Coronary artery stenosisCardiac disorders1/2630/263
Mitral valve disease mixedCardiac disorders0/2631/263
Myocardial ischaemiaCardiac disorders1/2630/263
PalpitationsCardiac disorders0/2631/263
Vitreous haemorrhageEye disorders0/2631/263
Most frequent other events
Most frequent other events
EventMK-1293Lantus™
HypoglycaemiaMetabolism and nutrition disorders142/263142/263
Upper respiratory tract infectionInfections and infestations16/26315/263

Baseline characteristics

The analysis population included all randomized participants.

Age, Continuous
Age, Continuous(Years)MK-1293Lantus™Total
Mean56.9 ± 10.057.1 ± 9.857.0 ± 9.9
Sex: Female, Male
Sex: Female, Male(Participants)MK-1293Lantus™Total
Female113125238
Male152141293
08

Study locations

No study locations are listed for this record.

09

References and documents

Publications

  • Hollander PA, Carofano WL, Lam RLH, Golm GT, Eldor R, Crutchlow MF, Marcos MC, Rendell MS, Home PD, Gallwitz B, Rosenstock J. Efficacy and safety of MK-1293 insulin glargine compared with originator insulin glargine (Lantus) in type 2 diabetes: A randomized, open-label clinical trial. Diabetes Obes Metab. 2018 Sep;20(9):2229-2237. doi: 10.1111/dom.13363. Epub 2018 Jun 10. PubMed 29761615 ↗

Individual participant data

Plan to share: Yes — https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 6, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02059187
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Feb 11, 2014
Start date
Feb 11, 2014
Primary completion
Mar 11, 2015
Completion
Mar 11, 2015
Results posted
Mar 8, 2017
Last update
Sep 6, 2018

Study contacts

Medical Director
study director · Merck Sharp & Dohme LLC

Oversight

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

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