A Study of Taspoglutide Versus Placebo for the Treatment of Obese Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Monotherapy

NCT ID: NCT00823992

Last Updated: 2016-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

305 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-05-31

Brief Summary

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This 2 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to placebo in obese patients with type 2 diabetes mellitus inadequately controlled with metformin monotherapy. Patients will be randomized to receive taspoglutide (10mg sc once weekly for 4 weeks followed by 20mg once weekly) or placebo sc, in addition to their prescribed, pre-existing metformin therapy.After the first 24 weeks, patients on placebo will be switched to taspoglutide 20mg once weekly (after 4 weeks on taspoglutide 10mg once weekly) The anticipated time on study treatment is 12 months, and the target sample size is 100-500 individuals.

Detailed Description

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Conditions

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Diabetes Mellitus Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

sc once weekly

taspoglutide

Group Type EXPERIMENTAL

taspoglutide

Intervention Type DRUG

10mg sc once weekly for 4 weeks, then 20mg sc once weekly

Interventions

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placebo

sc once weekly

Intervention Type DRUG

taspoglutide

10mg sc once weekly for 4 weeks, then 20mg sc once weekly

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* adult patients, 18-75 years of age;
* type 2 diabetes mellitus, receiving metformin at a stable dose of \>=1500mg/day for at least 12 weeks;
* HbA1c \>=6.5% and \<=9.5% at screening;
* BMI \>=30 and \<=50 kg/m2 at screening;
* stable weight +/-5% for at least 12 weeks prior to screening.

Exclusion Criteria

* history of type 1 diabetes or acute metabolic diabetic complications such as ketoacidosis or hyperosmolar coma within the past 6 months;
* evidence of clinically significant diabetic complications;
* myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the past 6 months.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Bermuda Dunes, California, United States

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La Jolla, California, United States

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Los Angeles, California, United States

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Mission Viejo, California, United States

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Brooksville, Florida, United States

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Miami, Florida, United States

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St. Petersburg, Florida, United States

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Atlanta, Georgia, United States

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Chicago, Illinois, United States

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Avon, Indiana, United States

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New Orleans, Louisiana, United States

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Bangor, Maine, United States

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Royal Oak, Michigan, United States

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Picayune, Mississippi, United States

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Clifton, New Jersey, United States

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Toms River, New Jersey, United States

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Albuquerque, New Mexico, United States

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New York, New York, United States

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Springfield Gardens, New York, United States

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Charlotte, North Carolina, United States

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Shelby, North Carolina, United States

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Norman, Oklahoma, United States

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Medford, Oregon, United States

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Clinton, South Carolina, United States

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Kingsport, Tennessee, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Midland, Texas, United States

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San Antonio, Texas, United States

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Vancouver, British Columbia, Canada

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Sherbrooke, Nova Scotia, Canada

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Etobicoke, Ontario, Canada

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Hamilton, Ontario, Canada

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Oakville, Ontario, Canada

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Toronto, Ontario, Canada

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Aschaffenburg, , Germany

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Berlin, , Germany

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Bochum, , Germany

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Dortmund, , Germany

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Dresden, , Germany

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Falkensee, , Germany

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Mainz, , Germany

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Münster, , Germany

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Neuwied, , Germany

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Ancona, , Italy

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Ravenna, , Italy

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Roma, , Italy

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Siena, , Italy

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Bitola, , North Macedonia

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Gniewkowo, , Poland

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Kamieniec Ząbkowicki, , Poland

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Lublin, , Poland

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Carolina, , Puerto Rico

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Rio Piedras, , Puerto Rico

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Río Grande, , Puerto Rico

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Kemerovo, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Ryazan, , Russia

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Saratov, , Russia

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Smolensk, , Russia

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Tyumen, , Russia

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Barcelona, , Spain

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Lleida, , Spain

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Oviedo, , Spain

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Bath, , United Kingdom

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Birmingham, , United Kingdom

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Glasgow, , United Kingdom

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Midsomer Norton, , United Kingdom

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Rotherham, , United Kingdom

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Countries

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United States Canada Germany Italy North Macedonia Poland Puerto Rico Russia Spain United Kingdom

Other Identifiers

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2008-005809-20

Identifier Type: -

Identifier Source: secondary_id

BC22092

Identifier Type: -

Identifier Source: org_study_id

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