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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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)

NCTNCT00641056 (opens ClinicalTrials.gov in a new tab)Other idH8O-MC-GWBR (DURATION - 3)

Overview

Status
Completed
Phase
Phase 3
Enrollment
467 participants (actual)
Sponsor
AstraZeneca · Industry
Design
Randomized · Open label (no masking)
Countries
16 countries

United States, Australia, Belgium, Czechia, Denmark, France, Germany, Greece, Hungary, Mexico, Netherlands, Puerto Rico, Russia, South Korea, Spain, Taiwan

Start
Apr 2008
Primary completion
May 2009
Completion
Nov 2009
First posted
21 Mar 2008 (estimated)
Last update posted
15 Jun 2015 (estimated)
Conditions
Type 2 Diabetes Mellitus

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200820092010
  1. Ph 3

    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)

    NCT00641056

    Apr 2008 to Nov 2009

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Exenatide Once WeeklyDrug
  • Insulin GlargineDrug

Arms2

  • Experimental

    1

  • Active comparator

    2

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in HbA1c From Baseline to Week 26

    Time frame · Baseline, Week 26

    Registry description

    Change in HbA1c from baseline to Week 26

Secondary outcomes(9)
  1. Percentage of Patients Achieving HbA1c <=7.0% at Week 26

    Time frame · Baseline, Week 26

    Registry description

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

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

    Time frame · Baseline, Week 26

    Registry description

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

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

    Time frame · Baseline, Week 26

    Registry description

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

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

    Time frame · Baseline, Week 26

    Registry description

    Change in BW (kg) from Baseline to Week 26

  5. Change in Total Cholesterol From Baseline to Week 26

    Time frame · Baseline, Week 26

    Registry description

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

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

    Time frame · Baseline, Week 26

    Registry description

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

  7. Ratio of Triglycerides at Week 26 to Baseline

    Time frame · Baseline, Week 26

    Registry description

    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.

  8. Change in Blood Pressure From Baseline to Week 26

    Time frame · Baseline, Week 26

    Registry description

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

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

    Time frame · Baseline to Week 26

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeLeast squares mean· Baseline, Week 26

Change in HbA1c From Baseline to Week 26

GroupValue (percentage of total hemoglobin)Spread
Exenatide Once Weekly-1.470.05
Insulin Glargine-1.310.06
Secondary and other outcome results(7)
Secondary outcomeNumber· Baseline, Week 26

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

GroupValue (percentage of patients)
Exenatide Once Weekly62.2
Insulin Glargine54.1
Secondary outcomeNumber· Baseline, Week 26

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

GroupValue (percentage of patients)
Exenatide Once Weekly43.2
Insulin Glargine28.4
Secondary outcomeLeast squares mean· Baseline, Week 26

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

GroupValue (mmol/L)Spread
Exenatide Once Weekly-2.130.16
Insulin Glargine-2.760.16
Secondary outcomeLeast squares mean· Baseline, Week 26

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

GroupValue (kg)Spread
Exenatide Once Weekly-2.630.20
Insulin Glargine1.420.20
Secondary outcomeLeast squares mean· Baseline, Week 26

Change in Total Cholesterol From Baseline to Week 26

GroupValue (mmol/L)Spread
Exenatide Once Weekly-0.120.06
Insulin Glargine-0.040.06
Secondary outcomeLeast squares mean· Baseline, Week 26

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

GroupValue (mmol/L)Spread
Exenatide Once Weekly-0.000.01
Insulin Glargine0.010.01
Secondary outcomeLeast squares mean· Baseline, Week 26

Ratio of Triglycerides at Week 26 to Baseline

GroupValue (ratio)Spread
Exenatide Once Weekly0.960.03
Insulin Glargine0.890.03

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Exenatide Once WeeklyPatients assigned to the Exenatide Once Weekly group received a 2 mg dose of exenatide injected once a week.–11 / 233100 / 233
Insulin GlarginePatients assigned to the Insulin Glargine group started insulin glargine treatment with 10 units per day, utilizing the INITIATE (Initiate Insulin by Aggressive Titration and Education) dosing and were instructed to adjust insulin doses to achieve a target blood glucose of 4.0-5.5 mmol/L.–10 / 22352 / 223

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies7

Studies that cite this trial.

Studies with results

5 studies on this page

Indexing hint: Randomized controlled trial · 2013

12 results

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.

Meloni et al. 2013Cardiovascular diabetologycited by 12

PMID 23522121PMC3622579DOI 10.1186/1475-2840-12-48PUB-23522121

CC BY12 results

Indexing hint: Randomized controlled trial · 2013

16 results

Efficacy, safety, and tolerability of exenatide once weekly in patients with type 2 diabetes mellitus: an integrated analysis of the DURATION trials.

Grimm et al. 2013Postgraduate medicinecited by 52

PMID 23748506DOI 10.3810/pgm.2013.05.2660PUB-23748506

Full text at the publisher16 results

PubMed tag: none · 2012

15 results

Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment.

Fineman et al. 2012Diabetes, obesity & metabolismcited by 117

PMID 22236356DOI 10.1111/j.1463-1326.2012.01561.xPUB-22236356

Full text at the publisher15 results

Indexing hint: Randomized controlled trial · 2012

8 results

Safety and efficacy of once-weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes over 84 weeks.

Diamant et al. 2012Diabetes carecited by 69

PMID 22357185PMC3308312DOI 10.2337/dc11-1233PUB-22357185

Free to read · publisher termsCC BY-NC-ND8 results

Indexing hint: Randomized controlled trial · 2010

2 results

Once weekly exenatide compared with insulin glargine titrated to target in patients with type 2 diabetes (DURATION-3): an open-label randomised trial.

Diamant et al. 2010Lancet (London, England)cited by 337

PMID 20609969DOI 10.1016/s0140-6736(10)60406-0PUB-20609969

Full text at the publisher2 results

More studies

2 studies on this page

PubMed tag: none · 2020

Corrected

Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease.

Guja et al. 2020Diabetes therapy : research, treatment and education of diabetes and related disorderscited by 6

PMID 32306296PMC7324446DOI 10.1007/s13300-020-00815-zPUB-32306296

Free to read · publisher termsCC BY-NC

Indexing hint: Randomized controlled trial · 2014

Corrected

Exenatide once weekly versus insulin glargine for type 2 diabetes (DURATION-3): 3-year results of an open-label randomised trial.

Diamant et al. 2014The lancet. Diabetes & endocrinologycited by 131

PMID 24731672DOI 10.1016/s2213-8587(14)70029-4PUB-24731672

Full text at the publisher

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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: * 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.

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