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)

Plain-language guide to NCT00641056: phase 3 randomized trial of Exenatide and Insulin Glargine, 467 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT00641056
Phase: phase 3
Status: completed
Start: 2008-04
Completion (planned or actual): 2009-05
Participants: 467 (actual)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Type 2 Diabetes Mellitus
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

The trial (phase 3) is built around Exenatide and Insulin Glargine.

It had two arms (groups): 1 (experimental) and 2 (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 467 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Has type 2 diabetes and at least 18 years of age at screening. Body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive, at screening.

The full record lists 6 inclusion and 22 exclusion criteria; among the exclusions: 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 had greater than three episodes of major hypoglycemia within 6 months prior to screening.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Exenatide group and the comparison group should start out alike.

The Exenatide group and the comparison group ran side by side rather than switching.

Everyone knew when Exenatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2008-04 with completion listed for 2009-05.

It ran at 75 sites in United States (12), Germany (9), Spain (7), Australia (6), Netherlands (6) and France (5).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in HbA1c From Baseline to Week 26 (time frame: Baseline, Week 26).

It also tracked 9 secondary outcomes, for example Change in Fasting Serum Glucose (FSG) From Baseline to Week 26, Change in Body Weight (BW) From Baseline to Week 26, Change in Total Cholesterol From Baseline to Week 26, Change in High-density Lipoprotein Cholesterol (HDL) From Baseline to Week 26, Ratio of Triglycerides at Week 26 to Baseline and Change in Blood Pressure From Baseline to Week 26.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Exenatide and Insulin Glargine in 467 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Exenatide compound page and the Insulin Glargine compound page, all human trials.

Our Notes on the Compounds

Exenatide: A 39-amino-acid GLP-1 receptor agonist first identified in Gila monster venom; sold as Byetta and Bydureon for type 2 diabetes.

Insulin Glargine: A long-acting insulin analog given once daily; brands include Lantus, Toujeo, Basaglar and Semglee.

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.