A Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise.

Completed · Phase 3 · Has a placebo group

Conditions studied: Diabetes Mellitus Type 2

In brief

This 3 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to placebo in patients with type 2 diabetes mellitus inadequately controlled with diet and exercise. Patients will be randomized to one of 3 treatment arms: taspoglutide 10mg sc once weekly, taspoglutide 20mg sc once weekly (after 4 weeks of taspoglutide 10mg sc once weekly) or placebo. 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 year, and the target sample size is 100-500 individuals.

Key facts

Study ID

NCT00744926

Run by

Hoffmann-La Roche

People needed

373

Starts

2008-08-01

Expected to finish

2010-04-01

Last updated by the study team

2016-07-28

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• adult patients, 18-80 years of age;
• drug naive patients with type 2 diabetes uncontrolled with diet and exercise;
• tested negative for anti-glutamic acid decarboxylase (anti-GAD) antibodies;
• C-peptide (fasting) >=1.0ng/mL
• HbA1c >=6.5% and <=10.0% at screening;
• BMI >=25 (>23 for Asians) and <=45kg/m2 at screening;
• stable weight +/- 5% for at least 12 weeks prior to screening.

You may not qualify if…

• 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;
• symptomatic poorly controlled diabetes;
• myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the previous 6 months;
• known hemoglobinopathy or chronic anemia.

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Santa Ana, California, United States
• Study site — Avon, Indiana, United States
• Study site — Pahrump, Nevada, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Greer, South Carolina, United States
• Study site — Mt. Pleasant, South Carolina, United States
• Study site — San Antonio, Texas, United States
• Study site — Richmond, Virginia, United States
• Study site — Adelaide, Australia
• Study site — St Leonards, Australia
• Study site — Guatemala City, Guatemala
• Study site — Guatemala City, Guatemala
• Study site — Haifa, Israel
• Study site — Haifa, Israel
• Study site — Holon, Israel
• Study site — Jerusalem, Israel
• Study site — Kfar Saba, Israel
• Study site — Petah Tikva, Israel
• Study site — Tel Aviv, Israel
• Study site — Acapulco, Mexico
• Study site — Aguascalientes, Mexico
• Study site — Chihuahua City, Mexico
• Study site — Hermosillo, Mexico
• Study site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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