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CompletedNCT00641056Updated Jun 15, 2015Results posted

Efficacy of Exenatide Once Weekly and Once-Daily Insulin Glargine in Patients With Type 2 Diabetes Treated With Metformin Alone or in Combination With Sulfonylurea (DURATION - 3)

A Phase 3 interventional study of Exenatide Once Weekly and Insulin Glargine in Type 2 Diabetes Mellitus, sponsored by AstraZeneca. Completed at 75 sites in 16 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-06-15.

Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
467
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to compare the effects of 2.0 mg exenatide once weekly and insulin glargine, titrated to glucose targets using the algorithm described by Yki- Järvinen et al.(2007), with respect to glycemic improvements, body weight, fasting lipids, safety, and tolerability.

02

Conditions studied

  • Type 2 Diabetes Mellitus

Keywords

  • diabetes
  • exenatide
  • exenatide once weekly
  • metformin
  • sulfonylurea
  • insulin glargine
  • Amylin
  • Lilly
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 467 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) 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

  • Has type 2 diabetes and at least 18 years of age at screening.
  • Hemoglobin A1c (HbA1c) of 7.1% to 11.0%, inclusive, at screening.
  • Body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at screening.
  • Have a history of stable body weight (not varying by >5% for at least 3 months prior to screening).
  • Have been treated with metformin(Met) for at least 3 months and have been taking a stable dose for at least 8 weeks prior to screening OR
  • Have been treated with metformin(Met) for at least 3 months and have been taking a stable dose for at least 8 weeks prior to screening and have been treated with SU for at least 3 months and have been taking a stable dose of at least an optimally effective dose of brand of SU for 8 weeks prior to screening.

Exclusion criteria

Exclusion Criteria:

  • Have had a clinically significant history of cardiac disease or presence of active cardiac disease within the year prior to inclusion in the study, including myocardial infarction, clinically significant arrhythmia, unstable angina, moderate to severe congestive heart failure, coronary artery bypass surgery, or angioplasty; or is expected to require coronary artery bypass surgery or angioplasty during the course of the study.
  • Have clinical signs or symptoms of liver disease, acute or chronic hepatitis.
  • Have a history of renal transplantation or are currently receiving renal dialysis.
  • Have active or untreated malignancy, or have been in remission from clinically significant malignancy (other than basal cell or squamous cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years.
  • Have had greater than three episodes of major hypoglycemia within 6 months prior to screening.
  • Have any contraindication for the oral antidiabetic agent which they use.
  • Have a known allergy or hypersensitivity to insulin glargine, exenatide once weekly, or excipients contained in these agents.
  • Are known to have active proliferative retinopathy.
  • Have been treated with drugs that promote weight loss (e.g., Xenical® [orlistat], Meridia® [sibutramine], Acomplia® [rimonabant], Acutrim® [phenylpropanolamine], or similar over-the-counter medications) within 3 months of screening.

  • Have been treated for longer than 2 weeks with any of the following excluded medications within 3 months prior to screening:

    • Insulin
    • Thiazolidinediones (e.g., Actos® [pioglitazone] or Avandia® [rosiglitazone])
    • Alpha-glucosidase inhibitors (e.g., Glyset® [miglitol] or Precose® [acarbose])
    • Meglitinides (e.g., Prandin® [repaglinide] or Starlix® [nateglinide]).
    • Byetta® (exenatide BID formulation)
    • Dipeptidyl peptidase (DPP)-4 inhibitors (e.g., Januvia™ [sitagliptin], Galvus® [vildagliptin])
    • Symlin® (pramlintide acetate).
  • Have had an organ transplant.
  • Have donated blood within 30 days of screening.
  • Have previously completed or withdrawn from this study or any other study investigating exenatide once weekly.
  • Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
  • Are currently enrolled in any other clinical study.
05

Study design

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

Study arms

  • Experimental
    1

    Drug: Exenatide Once Weekly

  • Active comparator
    2

    Drug: Insulin Glargine

Interventions

  • DrugExenatide Once Weekly

    subcutaneous injection, 2.0mcg, once weekly

  • DrugInsulin Glargine

    subcutaneous injection, variable dose, QD

06

What researchers measure

Primary outcomes

  1. Change in HbA1c From Baseline to Week 26

    Change in HbA1c from baseline to Week 26

    Time frame: Baseline, Week 26

Secondary outcomes

  1. Percentage of Patients Achieving HbA1c <=7.0% at Week 26

    Percentage of patients achieving HbA1c \<=7.0% at Week 26 (for patients with HbA1c \>7% at baseline)

    Time frame: Baseline, Week 26

  2. Percentage of Patients Achieving HbA1c <=6.5% at Week 26

    Percentage of patients achieving HbA1c \<=6.5% at Week 26 (for patients with HbA1c \>6.5% at baseline)

    Time frame: Baseline, Week 26

  3. Change in Fasting Serum Glucose (FSG) From Baseline to Week 26

    Change in FSG (mmol/L) from Baseline to Week 26

    Time frame: Baseline, Week 26

  4. Change in Body Weight (BW) From Baseline to Week 26

    Change in BW (kg) from Baseline to Week 26

    Time frame: Baseline, Week 26

  5. Change in Total Cholesterol From Baseline to Week 26

    Change in Total Cholesterol (mmol/L) from Baseline to Week 26

    Time frame: Baseline, Week 26

  6. Change in High-density Lipoprotein Cholesterol (HDL) From Baseline to Week 26

    Change in HDL (mmol/L) from Baseline to Week 26

    Time frame: Baseline, Week 26

  7. Ratio of Triglycerides at Week 26 to Baseline

    Ratio of Triglycerides (measured in mmol/L) at Week 26 to Baseline. Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.

    Time frame: Baseline, Week 26

  8. Change in Blood Pressure From Baseline to Week 26

    Change in Systolic Blood Pressure (mmHg) and Diastolic Blood Pressure (mmHg) from Baseline to Week 26

    Time frame: Baseline, Week 26

  9. Assessment on Event Rate of Treatment-emergent Hypoglycemic Episodes

    Major hypoglycemia: any episode with symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose or documented hypoglycemia (blood glucose \<3.0 mmol/L \[54 mg/dL\]) and required the assistance of another person. Minor hypoglycemia: any time a patient felt that he or she was experiencing a sign or symptom of hypoglycemia that was self-treated or resolved on its own and had a blood glucose level \<3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia.

    Time frame: Baseline to Week 26

07

Results

Posted Jul 4, 2012

Participant flow

Participant flow — Overall Study
MilestoneExenatide Once WeeklyInsulin Glargine
Started233234
Intent to treat (itt)233223
Completed204209
Not completed2925
Withdrew: Adverse event122
Withdrew: Lost to follow-up21
Withdrew: Physician decision31
Withdrew: Protocol violation20
Withdrew: Entry criteria not met30
Withdrew: Subject decision619
Withdrew: Sponsor decision12

Outcome measures

PrimaryChange in HbA1c From Baseline to Week 26

Change in HbA1c from baseline to Week 26

Time frame:
Baseline, Week 26
Reported as:
Least squares mean · percentage of total hemoglobin
Change in HbA1c From Baseline to Week 26
percentage of total hemoglobinExenatide Once WeeklyInsulin Glargine
Change in HbA1c From Baseline to Week 26-1.47 ± 0.05-1.31 ± 0.06
Statistical analysis
  • Exenatide Once Weekly vs Insulin Glargine · Mixed Models Analysis · p = 0.017 (No adjustments for multiplicity were performed) · Least squares mean difference: -0.16 · 95% CI -0.29 to -0.03
SecondaryPercentage of Patients Achieving HbA1c <=7.0% at Week 26

Percentage of patients achieving HbA1c \<=7.0% at Week 26 (for patients with HbA1c \>7% at baseline)

Time frame:
Baseline, Week 26
Reported as:
Number · percentage of patients
Percentage of Patients Achieving HbA1c <=7.0% at Week 26
percentage of patientsExenatide Once WeeklyInsulin Glargine
Percentage of Patients Achieving HbA1c <=7.0% at Week 2662.254.1
Statistical analysis
  • Exenatide Once Weekly vs Insulin Glargine · Cochran-Mantel-Haenszel · p = 0.097 (No adjustments for multiplicity were performed)
SecondaryPercentage of Patients Achieving HbA1c <=6.5% at Week 26

Percentage of patients achieving HbA1c \<=6.5% at Week 26 (for patients with HbA1c \>6.5% at baseline)

Time frame:
Baseline, Week 26
Reported as:
Number · percentage of patients
Percentage of Patients Achieving HbA1c <=6.5% at Week 26
percentage of patientsExenatide Once WeeklyInsulin Glargine
Percentage of Patients Achieving HbA1c <=6.5% at Week 2643.228.4
Statistical analysis
  • Exenatide Once Weekly vs Insulin Glargine · Cochran-Mantel-Haenszel · p = 0.002 (No adjustments for multiplicity were performed)
SecondaryChange in Fasting Serum Glucose (FSG) From Baseline to Week 26

Change in FSG (mmol/L) from Baseline to Week 26

Time frame:
Baseline, Week 26
Reported as:
Least squares mean · mmol/L
Change in Fasting Serum Glucose (FSG) From Baseline to Week 26
mmol/LExenatide Once WeeklyInsulin Glargine
Change in Fasting Serum Glucose (FSG) From Baseline to Week 26-2.13 ± 0.16-2.76 ± 0.16
Statistical analysis
  • Exenatide Once Weekly vs Insulin Glargine · Mixed Models Analysis · p = 0.001 (No adjustments for multiplicity were performed) · Least squares mean difference: 0.63 · 95% CI 0.25 to 1.00
SecondaryChange in Body Weight (BW) From Baseline to Week 26

Change in BW (kg) from Baseline to Week 26

Time frame:
Baseline, Week 26
Reported as:
Least squares mean · kg
Change in Body Weight (BW) From Baseline to Week 26
kgExenatide Once WeeklyInsulin Glargine
Change in Body Weight (BW) From Baseline to Week 26-2.63 ± 0.201.42 ± 0.20
Statistical analysis
  • Exenatide Once Weekly vs Insulin Glargine · Mixed Models Analysis · p = <.001 (No adjustments for multiplicity were performed) · Least squares mean difference: -4.05 · 95% CI -4.57 to -3.52
SecondaryChange in Total Cholesterol From Baseline to Week 26

Change in Total Cholesterol (mmol/L) from Baseline to Week 26

Time frame:
Baseline, Week 26
Reported as:
Least squares mean · mmol/L
Change in Total Cholesterol From Baseline to Week 26
mmol/LExenatide Once WeeklyInsulin Glargine
Change in Total Cholesterol From Baseline to Week 26-0.12 ± 0.06-0.04 ± 0.06
Statistical analysis
  • Exenatide Once Weekly vs Insulin Glargine · Mixed Models Analysis · p = 0.292 (No adjustments for multiplicity were performed) · Least squares mean difference: -0.07 · 95% CI -0.21 to 0.06
SecondaryChange in High-density Lipoprotein Cholesterol (HDL) From Baseline to Week 26

Change in HDL (mmol/L) from Baseline to Week 26

Time frame:
Baseline, Week 26
Reported as:
Least squares mean · mmol/L
Change in High-density Lipoprotein Cholesterol (HDL) From Baseline to Week 26
mmol/LExenatide Once WeeklyInsulin Glargine
Change in High-density Lipoprotein Cholesterol (HDL) From Baseline to Week 26-0.00 ± 0.010.01 ± 0.01
Statistical analysis
  • Exenatide Once Weekly vs Insulin Glargine · Mixed Models Analysis · p = 0.377 (No adjustments for multiplicity were performed) · Least squares mean difference: -0.02 · 95% CI -0.05 to 0.02
SecondaryRatio of Triglycerides at Week 26 to Baseline

Ratio of Triglycerides (measured in mmol/L) at Week 26 to Baseline. Log (Postbaseline Triglycerides) - log (Baseline Triglycerides); change from baseline to endpoint is presented as ratio of endpoint to baseline.

Time frame:
Baseline, Week 26
Reported as:
Least squares mean · ratio
Ratio of Triglycerides at Week 26 to Baseline
ratioExenatide Once WeeklyInsulin Glargine
Ratio of Triglycerides at Week 26 to Baseline0.96 ± 0.030.89 ± 0.03
Statistical analysis
  • Exenatide Once Weekly vs Insulin Glargine · Mixed Models Analysis · p = 0.077 (No adjustments for multiplicity were performed) · Geometric least squares mean ratio: 1.07 · 95% CI 0.99 to 1.15
SecondaryChange in Blood Pressure From Baseline to Week 26

Change in Systolic Blood Pressure (mmHg) and Diastolic Blood Pressure (mmHg) from Baseline to Week 26

Time frame:
Baseline, Week 26
Reported as:
Mean · mmHg
Change in Blood Pressure From Baseline to Week 26
mmHgExenatide Once WeeklyInsulin Glargine
Systolic Blood Pressure-3.03 ± 16.57-0.63 ± 14.88
Diastolic Blood Pressure-1.15 ± 10.08-0.72 ± 8.73
SecondaryAssessment on Event Rate of Treatment-emergent Hypoglycemic Episodes

Major hypoglycemia: any episode with symptoms consistent with hypoglycemia that resulted in loss of consciousness or seizure with prompt recovery in response to administration of glucagon or glucose or documented hypoglycemia (blood glucose \<3.0 mmol/L \[54 mg/dL\]) and required the assistance of another person. Minor hypoglycemia: any time a patient felt that he or she was experiencing a sign or symptom of hypoglycemia that was self-treated or resolved on its own and had a blood glucose level \<3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia.

Time frame:
Baseline to Week 26
Reported as:
Mean · rate per subject-year
Assessment on Event Rate of Treatment-emergent Hypoglycemic Episodes
rate per subject-yearExenatide Once Weekly With SUInsulin Glargine With SUExenatide Once Weekly No SUInsulin Glargine No SU
Major Hypoglycemia0.00 ± 0.0000.03 ± 0.0300.01 ± 0.0130.01 ± 0.013
Minor Hypoglycemia1.14 ± 0.1842.66 ± 0.2840.10 ± 0.0370.63 ± 0.091

Adverse events

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

Adverse event summary by group
GroupDeathsSeriousOther
Exenatide Once Weekly—11/233 (4.7%)100/233 (42.9%)
Insulin Glargine—10/223 (4.5%)52/223 (23.3%)
Most frequent serious events
Showing 10 of 23
Most frequent serious events
EventExenatide Once WeeklyInsulin Glargine
Chest painGeneral disorders1/2332/223
AnaemiaBlood and lymphatic system disorders0/2331/223
Bile duct stoneHepatobiliary disorders0/2331/223
Carotid artery stenosisNervous system disorders0/2331/223
CholecystitisHepatobiliary disorders0/2331/223
Colon polypectomySurgical and medical procedures0/2331/223
MyocarditisCardiac disorders0/2331/223
Peripheral nerve transpositionSurgical and medical procedures0/2331/223
PresyncopeNervous system disorders0/2331/223
Retinal detachmentEye disorders0/2331/223
Most frequent other events
Most frequent other events
EventExenatide Once WeeklyInsulin Glargine
NasopharyngitisInfections and infestations30/23339/223
NauseaGastrointestinal disorders30/2333/223
HeadacheNervous system disorders23/23316/223
DiarrhoeaGastrointestinal disorders20/2338/223
Injection site noduleGeneral disorders12/2330/223

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Exenatide Once WeeklyInsulin GlargineTotal
<=18 years000
Between 18 and 65 years184167351
>=65 years4956105
Age, Continuous
Age, Continuous(years)Exenatide Once WeeklyInsulin GlargineTotal
Mean57.6 ± 9.7258.3 ± 9.0857.9 ± 9.41
Sex: Female, Male
Sex: Female, Male(Participants)Exenatide Once WeeklyInsulin GlargineTotal
Female113100213
Male120123243
Glycosylated hemoglobin (HbA1c)
Glycosylated hemoglobin (HbA1c)(percentage of total hemoglobin)Exenatide Once WeeklyInsulin GlargineTotal
Mean8.32 ± 1.0948.29 ± 1.0208.31 ± 1.057
Weight
Weight(kg)Exenatide Once WeeklyInsulin GlargineTotal
Mean91.22 ± 18.58290.56 ± 16.34890.90 ± 17.509
Background Oral Antidiabetic Agent (OAD)
Background Oral Antidiabetic Agent (OAD)(participants)Exenatide Once WeeklyInsulin GlargineTotal
Metformin (Met)164157321
Met+Sulfonylurea (SU)6966135
08

Study locations

75 sites
  • Research Site
    Escondido, California, United States
  • Research Site
    Jacksonville, Florida, United States
  • Research Site
    Orlando, Florida, United States
  • Research Site
    West Palm Beach, Florida, United States
  • Research Site
    Honolulu, Hawaii, United States
  • Research Site
    Idaho Falls, Idaho, United States
  • Research Site
    Minneapolis, Minnesota, United States
  • Research Site
    St. Louis, Missouri, United States
  • Research Site
    Dayton, Ohio, United States
  • Research Site
    Ada, Oklahoma, United States
  • Research Site
    San Antonio, Texas, United States
  • Research Site
    Spokane, Washington, United States
  • Research Site
    Wollongong, New South Wales, Australia
  • Research Site
    Herston, Queensland, Australia
  • Research Site
    Adelaide, South Australia, Australia
  • Research Site
    Keswick, South Australia, Australia
  • Research Site
    Box Hill, Victoria, Australia
  • Research Site
    Geelong, Victoria, Australia
  • Research Site
    Brussels, Belgium
  • Research Site
    Edegem, Belgium
  • Research Site
    Melnik, Czech Republic
  • Research Site
    Praha, Czech Republic
  • Research Site
    Stodulky, Czech Republic
  • Research Site
    Aalborg, Denmark
  • Research Site
    Arhus C, Denmark
  • Research Site
    Herlev, Denmark
  • Research Site
    Koge, Denmark
  • Research Site
    Angers, France
  • Research Site
    Corbeil Essoness, France
  • Research Site
    Nancy, France
  • Research Site
    Nanterre, France
  • Research Site
    Toulouse, France
  • Research Site
    Bad Mergentheim, Germany
  • Research Site
    Dresden, Germany
  • Research Site
    Essen, Germany
  • Research Site
    Falkensee, Germany
  • Research Site
    Fulda, Germany
  • Research Site
    Hamburg-Othmarschen, Germany
  • Research Site
    Munster, Germany
  • Research Site
    Rothenburg an der fulda, Germany
  • Research Site
    Speyer, Germany
  • Research Site
    Athens, Greece
  • Research Site
    Thessaloniki, Greece
  • Research Site
    Budapest, Hungary
  • Research Site
    Eger, Hungary
  • Research Site
    Gyula, Hungary
  • Research Site
    Pecs, Hungary
  • Research Site
    Gyeonggi-Do, Korea, Republic of
  • Research Site
    Seoul, Korea, Republic of
  • Research Site
    Merida, Mexico
  • Research Site
    Mexico City, Mexico
  • Research Site
    Tampico, Mexico
  • Research Site
    Tijuana, Mexico
  • Research Site
    Amsterdam, Netherlands
  • Research Site
    Gouda, Netherlands
  • Research Site
    Hoogeveen, Netherlands
  • Research Site
    Rotterdam, Netherlands
  • Research Site
    Zwijndrecht, Netherlands
  • Research Site
    Zwolle, Netherlands
  • Research Site
    Caguas, Puerto Rico
  • Research Site
    Yabucoa, Puerto Rico
  • Research Site
    Moscow, Russian Federation
  • Research Site
    Rostov-on-Don, Russian Federation
  • Research Site
    St. Petersburg, Russian Federation
  • Research Site
    Alicante, Spain
  • Research Site
    Alzira-Valencia, Spain
  • Research Site
    Barcelona, Spain
  • Research Site
    Bilbao, Spain
  • Research Site
    Madrid, Spain
  • Research Site
    Malaga, Spain
  • Research Site
    Teruel, Spain
  • Research Site
    Chia-Yi, Taiwan
  • Research Site
    Tainan County, Taiwan
  • Research Site
    Taipei, Taiwan
  • Research Site
    Taoyuan, Taiwan
09

References and documents

Publications

  • Diamant M, Van Gaal L, Stranks S, Guerci B, MacConell L, Haber H, Scism-Bacon J, Trautmann M. Safety and efficacy of once-weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes over 84 weeks. Diabetes Care. 2012 Apr;35(4):683-9. doi: 10.2337/dc11-1233. Epub 2012 Feb 22. PubMed 22357185 ↗
  • Guja C, Frias JP, Suchower L, Hardy E, Marr G, Sjostrom CD, Jabbour SA. Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease. Diabetes Ther. 2020 Jul;11(7):1467-1480. doi: 10.1007/s13300-020-00815-z. Epub 2020 Apr 18. Erratum In: Diabetes Ther. 2020 Dec;11(12):3011-3013. doi: 10.1007/s13300-020-00842-w. PubMed 32306296 ↗
  • Diamant M, Van Gaal L, Guerci B, Stranks S, Han J, Malloy J, Boardman MK, Trautmann ME. Exenatide once weekly versus insulin glargine for type 2 diabetes (DURATION-3): 3-year results of an open-label randomised trial. Lancet Diabetes Endocrinol. 2014 Jun;2(6):464-73. doi: 10.1016/S2213-8587(14)70029-4. Epub 2014 Apr 4. Erratum In: Lancet Diabetes Endocrinol. 2014 Jun;2(6):e13. PubMed 24731672 ↗
  • Grimm M, Han J, Weaver C, Griffin P, Schulteis CT, Dong H, Malloy J. Efficacy, safety, and tolerability of exenatide once weekly in patients with type 2 diabetes mellitus: an integrated analysis of the DURATION trials. Postgrad Med. 2013 May;125(3):47-57. doi: 10.3810/pgm.2013.05.2660. PubMed 23748506 ↗
  • Meloni AR, DeYoung MB, Han J, Best JH, Grimm M. Treatment of patients with type 2 diabetes with exenatide once weekly versus oral glucose-lowering medications or insulin glargine: achievement of glycemic and cardiovascular goals. Cardiovasc Diabetol. 2013 Mar 23;12:48. doi: 10.1186/1475-2840-12-48. PubMed 23522121 ↗
  • Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10. PubMed 22236356 ↗
  • Diamant M, Van Gaal L, Stranks S, Northrup J, Cao D, Taylor K, Trautmann M. Once weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes (DURATION-3): an open-label randomised trial. Lancet. 2010 Jun 26;375(9733):2234-43. doi: 10.1016/S0140-6736(10)60406-0. PubMed 20609969 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00641056
Lead sponsor
AstraZeneca
Collaborators
Eli Lilly and Company
Responsible party
Sponsor
First posted
Mar 21, 2008
Start date
Apr 2008
Primary completion
May 2009
Completion
Nov 2009
Results posted
Jul 4, 2012
Last update
Jun 15, 2015

Study contacts

Chief Medical Officer, MD
study director · Eli Lilly and Company

Oversight

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

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