Trial information

A Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Plus Pioglitazone.

Status: Recruiting

Protocol number: BC20963

Sponsor: Hoffmann-La Roche

Company division: Pharmaceutical

Official Scientific Title: A multicenter, randomized, double-blind, placebo-controlled study to assess the safety, tolerability and effect of taspoglutide on glycemic control compared to placebo in patients with type II diabetes mellitus inadequately controlled with metformin plus pioglitazone

Brief summary: This 3 arm study will assess the efficacy of taspoglutide on glycemic control (as assessed by HbA1c) in patients with type 2 diabetes mellitus inadequately controlled with metformin plus pioglitazone, compared to placebo after 24 weeks of treatment. Patients will be randomized to one of 3 treatment arms: taspoglutide 10mg once weekly, taspoglutide 20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly) or placebo, in addition to their continued stable metformin plus pioglitazone treatment. After the first 24 weeks patients on placebo will be switched to taspoglutide 10mg once weekly or taspoglutide 20mg once weekly (after 4 weeks of taspoglutide 10mg once weekly. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals. Target sample size is 330.

Study phase: III

Study type: Interventional; Treatment; Randomized; Double Blind; Placebo; Parallel; Safety/Efficacy study

Condition: Diabetes Mellitus, Type 2

Intervention type: Drug

Intervention name: taspoglutide

Primary outcome: 1. Absolute change from baseline in HbA1c Time frame: 24 weeks

Key secondary outcomes: 1. Change from baseline in fasting plasma glucose; change from baseline in body weight; responder rates for HbA1c (target <=7.0%, <=6.5%); responder rates for body weight; beta cell function. Time frame: 24 weeks 2. Safety: adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies. Time frame: Throughout the study

Inclusion criteria:

• adult patients, 18-75 years age;
• type 2 diabetes receiving pioglitazone (>= 30 mg/day) and metformin (>= 1500 mg/day) for at least 12 weeks prior to screening;
• HbA1c >=7.0% and <=10.0% at screening;
• BMI >= 25 (>23 for Asians) and <=45 kg/m2 at screening;
• stable weight +/-5% for at least 12 weeks prior to screening.

Exclusion criteria:

• history of type 1 diabetes mellitus or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma in the previous 6 months;
• evidence of clinically significant diabetic complications;
• clinically symptomatic gastrointestinal disease;
• myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the previous 6 months;
• known hemoglobinopathy or chronic anemia.

Gender: Males or Females

Age limits: Min: 18 Years Max: 75 Years

Accepts healthy volunteers: No

Anticipated start date: October, 2008

Trial registration date: 08/29/2008

Date last updated: 12/19/2008

Link to trial result

This trial is being conducted at the following locations:

Brazil

• Brasilia
• Campinas - Sp
• Forlateza
• Fortaleza
• Fortaleza - Ce
• Goiania - Go
• Maringa - Pr
• Mogi Das Cruzes - Sp
• Passo Fundo
• Porto Alegre
• Recife
• Rio De Janeiro
• Sao Paulo
• São Paulo
• Sao Paulo - Sp

Canada

• Hamilton, ON
• London, ON
• Toronto, ON
• Montreal, QC
• Pointe-Claire, QC

Costa Rica

• San Jose

France

• Bondy
• Dijon
• Nantes
• Narbonne

Germany

• Mainz

Guatemala

• Guatemala

Mexico

• Chihuahua
• Guadalajara
• Mexico City
• Morelia

United States

• Birmingham, AL
• Huntsville, AL
• Muscle Shoals, AL
• Phoenix, AZ
• Buena Park, CA
• Loma Linda, CA
• Roseville, CA
• San Diego , CA
• Walnut Creek, CA
• Wheatridge, CO
• Hamden, CT
• Washington, DC
• Bradenton, FL
• Chiefland, FL
• Fort Myers, FL
• Gainesville, FL
• Hollywood, FL
• Miami, FL
• New Port Richey , FL
• Ocala, FL
• Plantation, FL
• Tampa, FL
• Nampa, ID
• Aurora, IL
• Vernon Hills, IL
• Evansville, IN
• Topeka, KS
• Lexington, KY
• Madisonville, KY
• New Orleans, LA
• Frederick, MD
• Oxon Hill, MD
• Detroit, MI
• Kalamazoo, MI
• Biloxi, MS
• Olive Branch, MS
• St Peters, MO
• Omaha, NE
• Las Vegas, NV
• Hudson, NY
• Lake Success, NY
• Charlotte, NC
• Mooresville, NC
• Wilmington, NC
• Bismarck, ND
• Athens, OH
• Cincinnati, OH
• Kettering , OH
• Norman, OK
• Medford, OR
• Beaver, PA
• Bensalem, PA
• Carlisle, PA
• Levittown, PA
• Melrose Park, PA
• Pittsburgh, PA
• Carolina, PR
• Guyanabo, San Juan, PR
• San Juan, PR
• Cranston, RI
• Bellaire, TX
• Dallas, TX
• Houston, TX
• San Antonio, TX
• Salt Lake City, UT
• Federal Way, WA