A Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Once Weekly to Those of Sitagliptin and Pioglitazone,in Subjects with Type 2 Diabetes Treated with Metformin (DURATION - 2)

Study identifier:BCB106 (DURATION - 2)

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Randomized, Double-Blind, Parallel-Group, Multicenter Study to Compare the Glycemic Effects, Safety, and Tolerability of Exenatide Long-Acting Release(Once Weekly) to Those of Sitagliptin and a Thiazolidinedione in Subjects with Type 2 Diabetes Mellitus Treated with Metformin

Medical condition

Type 2 Diabetes Mellitus

Phase

Phase 3

Healthy volunteers

Study drug

exenatide once weekly, sitagliptin, pioglitazone, placebo tablet, placebo once weekly

Sex

All

Actual Enrollment

514

Study type

Interventional

Age

18 Years +

Date

Study Start Date: 01 Jan 2008

Primary Completion Date: 01 Feb 2009

Study Completion Date: 01 Jul 2009

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2015 by AstraZeneca Pharmaceuticals

Collaborators

Eli Lilly and Company

Inclusion and exclusion criteria

Inclusion Criteria

- Has been diagnosed with type 2 diabetes mellitus
- Has a hemoglobin-specific A1c fraction (HbA1c) of 7.1% to 11.0%, inclusive, at study start
- Has a body mass index (BMI)of 25 kg/m2 to 45 kg/m2, inclusive, at study start
- Has been on a stable treatment regimen of metformin for a minimum of 2 months prior to study start
- Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 2 months prior to study start:
a. Hormone replacement therapy (female subjects)
b. Oral contraceptives (female subjects)
c. Antihypertensive agents
d. Lipid-lowering agents
e. Thyroid replacement therapy
f. Antidepressant agents
g. Drugs known to affect body weight, including prescription medications (e.g. orlistat [XENICAL®], sibutramine [MERIDIA®], topiramate [TOPAMAX®]) and over-the-counter antiobesity agents

Exclusion Criteria

- Has been previously exposed to exenatide once weekly
- Has donated blood within 60 days of study start or is planning to donate blood during the study
- Currently being treated, or is expected to require or undergo treatment with any of the following treatment-excluded medications:
a. Exenatide (BYETTA®) or any Dipeptidyl peptidase-4 DPP-4)inhibitor, sulfonylurea (SU), thiazolidinedione (TZD), or glucagon-like peptide (GLP)-1 analog within 3 months prior to study start
b. Alpha-glucosidase inhibitor, meglitinide, nateglinide, or pramlintide (SYMLIN®) within 30 days of study start
c. Insulin within 2 weeks of study start or for more than 1 week within 3 months of study start
d. Systemic corticosteroids by oral, intravenous, or intramuscular route; or potent, inhaled, or intrapulmonary (including ADVAIR®) steroids known to have a high rate of systemic absorption
e. Drugs interacting with the CYP2C8 enzyme system, including gemfibrozil (LOPID®) and rifampin
- Has received any investigational drug within 1 month (or five half-lives of investigational drug, whichever is greater) of study start
- Has previously experienced a clinically significant adverse event (e.g., significant edema) related to TZD or DPP-4 inhibitor use

No locations available

Arms	Assigned Interventions
Experimental: 1	Drug: exenatide once weekly subcutaneous injection, 2.0mg, once a week Drug: placebo tablet oral tablet, once a day
Active Comparator: 2	Drug: sitagliptin oral tablet, 100mg, once a day Other Name: Januvia Drug: placebo once weekly subcutaneous injection, once a week
Active Comparator: 3	Drug: pioglitazone oral tablet, 45mg, once a day Drug: placebo once weekly subcutaneous injection, once a week

Documents available

Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center Call Center

1-877-240-9479

[email protected]

Investigators

Principal Investigator

Lisa Porter

Amylin Pharmaceuticals