Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using a Thiazolidinedione or a Thiazolidinedione and Metformin - Full Text View

Sponsors and Collaborators:	Amylin Pharmaceuticals, Inc. Eli Lilly and Company
Information provided by:	Amylin Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00603239

Purpose

This study will assess safety and efficacy of exenatide in combination with a thiazolidinedione (TZD) and a TZD plus metformin over 26 weeks in adult patients with type 2 diabetes who have not achieved adequate glycemic control.

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: exenatide Drug: placebo	Phase III

MedlinePlus related topics: Diabetes

Drug Information available for: Exenatide Metformin Metformin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Safety and Efficacy of Exenatide in Patients With Type 2 Diabetes Using a Thiazolidinedione or a Thiazolidinedione and Metformin

Further study details as provided by Amylin Pharmaceuticals, Inc.:

Primary Outcome Measures:

To test the hypothesis that glycemic control, as measured by the change in HbA1c from baseline to endpoint with exenatide, is superior to placebo in patients with type 2 diabetes and inadequate glycemic control taking a TZD alone or a TZD plus metformin. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare exenatide and placebo groups with respect to: proportion of patients achieving HbA1c ≤7% and ≤6.5%; fasting serum glucose; body weight; waist circumference. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
To compare exenatide and placebo groups with respect to: beta-cell function and insulin sensitivity; health outcome measures; incidence and rate of hypoglycemic events; safety and tolerability. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	180
Study Start Date:	January 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: exenatide subcutaneous injection, 5mcg or 10mcg, twice a day
2: Placebo Comparator	Drug: placebo subcutaneous injection, volume equivalent to 5mcg or 10mcg of active drug, twice a day

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosed with type 2 diabetes
If treated with a thiazolidinedione (TZD) alone, the TZD dose must have been stable for at least 120 days
The dose of TZD must be: Rosiglitazone (≥4 mg/day) or pioglitazone (≥30 mg/day)
The metformin dose has been stable for at least 90 days
Have suboptimal glycemic control as evidenced by an HbA1c between 7.1% and 10.0%, inclusive.
Have a body mass index (BMI): 25 kg/m2 < BMI < 45 kg/m2.

Exclusion Criteria:

Have participated in this study previously or any other study using exenatide (AC2993/LY2148568) or glucagon-like peptide-1 (GLP-1) analogs, or have been previously treated with exenatide or GLP-1 analogs
Have participated in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days of screening. This criterion includes drugs that have not received regulatory approval for any indication at the time of study entry.
Have been treated with exogenous insulin for more than 1 week within the 2 months prior to screening
Used drugs for weight loss (e.g., orlistat, rimonabant, sibutramine, or similar over-the-counter medications) within 3 months prior to screening.
Are currently treated with any of the following excluded medications:
- Sulfonylurea or meglitinide derivatives (e.g., repaglinide or nateglinide) within 3 months prior to screening
- Alpha-glucosidase inhibitor (e.g., miglitol or acarbose) within 3 months of screening
- DPP-4 inhibitors (e.g., sitagliptin or vildagliptin) within 3 months prior to screening
- Pramlintide acetate injection within 3 months prior to screening
- Drugs that directly affect gastrointestinal motility, including, but not limited to: Metoclopramide, cisapride, and chronic macrolide antibiotics
- Are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within the 4 weeks immediately preceding study start

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00603239

Show 25 Study Locations

Sponsors and Collaborators

Amylin Pharmaceuticals, Inc.

Eli Lilly and Company

Investigators

Study Director:

James Malone, MD

Eli Lilly and Company

More Information

Responsible Party:	Eli Lilly and Company ( James Malone, MD, Study Director )
Study ID Numbers:	H8O-MC-GWCG
Study First Received:	January 17, 2008
Last Updated:	August 15, 2008
ClinicalTrials.gov Identifier:	NCT00603239
Health Authority:	United States: Food and Drug Administration; Mexico: Ministry of Health; South Africa: Medicines Control Council; Canada: Health Canada; Romania: National Medicines Agency

Keywords provided by Amylin Pharmaceuticals, Inc.:

diabetes
exenatide
metformin
thiazolidinedione

Byetta
Amylin
Lilly

Study placed in the following topic categories:

Metabolic Diseases
Exenatide
Metformin
Diabetes Mellitus, Type 2
Diabetes Mellitus

2,4-thiazolidinedione
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

Additional relevant MeSH terms:

Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009