Primary outcomeLeast squares mean· Baseline, Week 26
Change in HbA1c From Baseline to Week 26
| Group | Value (percentage of total hemoglobin) | Spread |
|---|---|---|
| Exenatide Once Weekly | -1.53 | 0.07 |
| Metformin | -1.48 | 0.07 |
| Pioglitazone | -1.63 | 0.08 |
| Sitagliptin | -1.15 | 0.08 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataSafety and Efficacy of Exenatide Once Weekly Injection Versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients With Type 2 Diabetes (DURATION-4)
NCTNCT00676338 (opens ClinicalTrials.gov in a new tab)Other idH8O-MC-GWCH (DURATION - 4)
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 820 participants (actual)
- Sponsor
- AstraZeneca · Industry
- Design
- Randomized · Double masking
- Countries
22 countries
United States, Argentina, Belgium, Brazil, Canada, France, Germany, Hungary, India, Israel, Italy, Mexico, Poland, Puerto Rico, Romania, Russia, Slovakia, South Africa, South Korea, Spain, Turkey (Türkiye), United Kingdom
- Start
- Nov 2008
- Primary completion
- Jul 2010
- Completion
- Jan 2011
- First posted
- 13 May 2008 (estimated)
- Last update posted
- 9 Apr 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
20082009201020112012
- Ph 3
Safety and Efficacy of Exenatide Once Weekly Injection Versus Metformin, Dipeptidyl Peptidase-4 Inhibitor, or Thiazolidinedione as Monotherapy in Drug-Naive Patients With Type 2 Diabetes (DURATION-4)
NCT00676338Nov 2008 to Jan 2011
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This study will compare the effects of 2.0 mg exenatide once weekly injection as monotherapy to 3 active comparators(metformin, dipeptidyl peptidase-4 inhibitor, and thiazolidinedione) in drug naive patients with type 2 diabetes treated with diet and exercise.
Interventions
- exenatide once weeklyDrug
- metforminDrug
- sitagliptinDrug
- pioglitazoneDrug
Arms4
Experimental
Exenatide Once Weekly
Active comparator
Metformin
Active comparator
Sitagliptin
Active comparator
Pioglitazone
Primary outcomes2
Outcomes the sponsor listed as primary.
Change in HbA1c From Baseline to Week 26
Time frame · Baseline, Week 26
Registry description
Change in HbA1c from baseline to Week 26.
Percentage of Patients Achieving HbA1c <=7% at Week 26
Time frame · Baseline, Week 26
Registry description
Percentage of patients achieving HbA1c \<=7% at Week 26 (for patients with baseline HbA1c \>7%).
Secondary outcomes(9)
Change in Fasting Serum Glucose (FSG) From Baseline to Week 26
Time frame · Baseline, Week 26
Registry description
Change in FSG from baseline to Week 26.
Change in Body Weight From Baseline to Week 26
Time frame · Baseline, Week 26
Registry description
Change in Body Weight from baseline to Week 26.
Change in Fasting Total Cholesterol (TC) From Baseline to Week 26
Time frame · Baseline, Week 26
Registry description
Change in Fasting TC from baseline to Week 26.
Change in Fasting High-Density Lipoprotein (HDL) From Baseline to Week 26
Time frame · Baseline, Week 26
Registry description
Change in Fasting HDL from baseline to Week 26.
Ratio of Fasting Triglycerides at Week 26 to Baseline
Time frame · Baseline, Week 26
Registry description
Ratio of Fasting Triglycerides (measured in mmol/L) at Week 26 to baseline. Log(Post-baseline Triglycerides) - log(Baseline Triglycerides); change from baseline to Week 26 is presented as ratio of endpoint to baseline.
Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events
Time frame · Baseline to Week 26
Registry description
Major hypoglycemia is defined as any event that has symptoms consistent with hypoglycemia resulting in loss of consciousness or seizure that shows prompt recovery in response to administration of glucagon or glucose, or documented hypoglycemia (blood glucose \<3.0 mmol/L \[54 mg/dL\]) requiring the assistance of another person because of severe impairment in consciousness or behavior (whether or not symptoms of hypoglycemia are detected by the patient). Mean event rate = total number of events for all subjects in a treatment regimen / the total number of subject years of exposure for all subjects in that treatment. Standard error = square root of (total number of events / (subject years of exposure)\*\*2).
Assessment on Event Rate of Treatment-Emergent Minor Hypoglycemic Events
Time frame · Baseline to Week 26
Registry description
Minor hypoglycemia is defined as a sign or symptom associated with hypoglycemia that is either self-treated by the patient or resolves on its own AND has a concurrent finger stick blood glucose \<3.0 mmol/L (54 mg/dL) and not classified as major hypoglycemia. Mean event rate = total number of events for all subjects in a treatment regimen / the total number of subject years of exposure for all subjects in that treatment. Standard error = square root of (total number of events / (subject years of exposure)\*\*2).
Change in Systolic Blood Pressure From Baseline to Week 26.
Time frame · Baseline, Week 26
Registry description
Change in Systolic Blood Pressure from baseline to Week 26.
Change in Diastolic Blood Pressure From Baseline to Week 26.
Time frame · Baseline, Week 26
Registry description
Change in Diastolic Blood Pressure from baseline to Week 26.
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 outcomeNumber· Baseline, Week 26
Percentage of Patients Achieving HbA1c <=7% at Week 26
| Group | Value (percentage of patients) |
|---|---|
| Exenatide Once Weekly | 64.2 |
| Metformin | 57.3 |
| Pioglitazone | 63.3 |
| Sitagliptin | 45.5 |
Secondary and other outcome results(6)
Secondary outcomeLeast squares mean· Baseline, Week 26
Change in Fasting Serum Glucose (FSG) From Baseline to Week 26
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Exenatide Once Weekly | -2.25 | 0.14 |
| Metformin | -1.98 | 0.14 |
| Pioglitazone | -2.57 | 0.18 |
| Sitagliptin | -1.13 | 0.18 |
Secondary outcomeLeast squares mean· Baseline, Week 26
Change in Body Weight From Baseline to Week 26
| Group | Value (kg) | Spread |
|---|---|---|
| Exenatide Once Weekly | -2.04 | 0.21 |
| Metformin | -2.00 | 0.21 |
| Pioglitazone | 1.52 | 0.26 |
| Sitagliptin | -0.76 | 0.26 |
Secondary outcomeLeast squares mean· Baseline, Week 26
Change in Fasting Total Cholesterol (TC) From Baseline to Week 26
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Exenatide Once Weekly | -0.24 | 0.06 |
| Metformin | -0.22 | 0.06 |
| Pioglitazone | 0.09 | 0.08 |
| Sitagliptin | -0.01 | 0.08 |
Secondary outcomeLeast squares mean· Baseline, Week 26
Change in Fasting High-Density Lipoprotein (HDL) From Baseline to Week 26
| Group | Value (mmol/L) | Spread |
|---|---|---|
| Exenatide Once Weekly | 0.01 | 0.01 |
| Metformin | 0.07 | 0.01 |
| Pioglitazone | 0.17 | 0.02 |
| Sitagliptin | 0.04 | 0.02 |
Secondary outcomeLeast squares mean· Baseline, Week 26
Ratio of Fasting Triglycerides at Week 26 to Baseline
| Group | Value (ratio) | Spread |
|---|---|---|
| Exenatide Once Weekly | 0.98 | 0.03 |
| Metformin | 0.96 | 0.03 |
| Pioglitazone | 0.85 | 0.03 |
| Sitagliptin | 0.94 | 0.04 |
Secondary outcomeMean· Baseline to Week 26
Assessment on Event Rate of Treatment-emergent Major Hypoglycemic Events
| Group | Value (events per subject-year) | Spread |
|---|---|---|
| Exenatide Once Weekly | 0.00 | 0.000 |
| Metformin | 0.00 | 0.000 |
| Pioglitazone | 0.00 | 0.000 |
| Sitagliptin | 0.00 | 0.000 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Exenatide Once WeeklyExenatide once weekly (subcutaneous injection of 2 mg exenatide, once a week) + daily oral placebo | – | 4 / 248 | 109 / 248 |
| MetforminMetformin (1000 mg/day for 2 weeks, then 1500 mg/day for 2 weeks, then 2000 mg/day for 22 weeks) + weekly subcutaneous placebo injection | – | 12 / 246 | 94 / 246 |
| PioglitazonePioglitazone (30 mg/day for 4 weeks, then 45 mg/day for 22 weeks) + weekly subcutaneous placebo injection | – | 9 / 163 | 57 / 163 |
| SitagliptinSitagliptin (100 mg/day for 26 weeks) + weekly subcutaneous placebo injection | – | 3 / 163 | 55 / 163 |
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
Studies5
Studies that cite this trial.
Studies with results
4 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
Indexing hint: Randomized controlled trial · 2013
8 results
Efficacy and tolerability of exenatide once weekly versus sitagliptin in patients with type 2 diabetes mellitus: a retrospective analysis of pooled clinical trial data.
Malloy et al. 2013Postgraduate medicinecited by 6
PMID 23748507DOI 10.3810/pgm.2013.05.2661PUB-23748507
Full text at the publisher8 results
Indexing hint: Randomized controlled trial · 2012
10 results
Efficacy and safety of exenatide once weekly versus metformin, pioglitazone, and sitagliptin used as monotherapy in drug-naive patients with type 2 diabetes (DURATION-4): a 26-week double-blind study.
Russell-Jones et al. 2012Diabetes carecited by 273
PMID 22210563PMC3263915DOI 10.2337/dc11-1107PUB-22210563
Free to read · publisher termsCC BY-NC-ND10 results
More studies
1 study 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
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* have type 2 diabetes and are treated with diet and exercise alone.
* at least 18 years of age.
* HbA1c between 7.1% and 11.0%, inclusive.
* Body mass index (BMI) of 23 kg/m2 to 45 kg/m2, inclusive.
* Have a history of stable body weight (not varying by \>5% for at least 3 months prior to screening).
Exclusion Criteria:
* Have 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
* 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 history of severe GI disorder (e.g., gastroparesis)
* Have a history of acute or chronic pancreatitis.
* 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 with any antidiabetic agent for more than 7 days within 3 months prior to screening.
* Have had an organ transplant.
* Have previously completed or discontinued study drug in this study, 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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