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

July 26, 2016 updated by: Hoffmann-La Roche

A Randomized, Double-blind, Placebo-controlled Study to Assess the Effect of Taspoglutide on Glycemic Control, and Its Safety and Tolerability, in Obese Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Monotherapy.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

305

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1L8
    • Nova Scotia
      • Sherbrooke, Nova Scotia, Canada, J1G 2E8
    • Ontario
      • Etobicoke, Ontario, Canada, M9R 4E1
      • Hamilton, Ontario, Canada, L8N 3Z5
      • Oakville, Ontario, Canada, L6H 3P1
      • Toronto, Ontario, Canada, M9W 4L6
  • Germany
      • Aschaffenburg, Germany, 63739
      • Berlin, Germany, 10115
      • Bochum, Germany, 44791
      • Dortmund, Germany, 44137
      • Dresden, Germany, 01307
      • Falkensee, Germany, 14612
      • Mainz, Germany, 55116
      • Münster, Germany, 48145
      • Neuwied, Germany, 56564
  • Italy
      • Ancona, Italy, 60131
      • Ravenna, Italy, 48100
      • Roma, Italy, 00161
      • Siena, Italy, 53100
  • Macedonia, The Former Yugoslav Republic of
      • Bitola, Macedonia, The Former Yugoslav Republic of, 7000
  • Poland
      • Gniewkowo, Poland, 88-140
      • Kamieniec Zabkowicki, Poland, 57-230
      • Lublin, Poland, 20-044
  • Puerto Rico
      • Carolina, Puerto Rico, 00983
      • Rio Grande, Puerto Rico, 00745
      • Rio Piedras, Puerto Rico, 00921
  • Russian Federation
      • Kemerovo, Russian Federation, 650002
      • Moscow, Russian Federation, 105229
      • Moscow, Russian Federation, 117036
      • Moscow, Russian Federation, 115280
      • Ryazan, Russian Federation, 390026
      • Saratov, Russian Federation, 410002
      • Smolensk, Russian Federation, 214019
      • Tumen, Russian Federation, 625023
  • Spain
      • Barcelona, Spain, 08036
      • Lerida, Spain, 25198
      • Oviedo, Spain, 33006
  • United Kingdom
      • Bath, United Kingdom, BA2 4BY
      • Birmingham, United Kingdom, B9 5SS
      • Glasgow, United Kingdom, G45 9AW
      • Midsomer Norton, United Kingdom, BA3 2UH
      • Rotherham, United Kingdom, S65 1DA
  • United States
    • California
      • Bermuda Dunes, California, United States, 92203
      • Lajolla, California, United States, 92037
      • Los Angeles, California, United States, 90057
      • Mission Viejo, California, United States, 92691
    • Florida
      • Brooksville, Florida, United States, 34601
      • Miami, Florida, United States, 33133
      • St. Petersburg, Florida, United States, 33709
    • Georgia
      • Atlanta, Georgia, United States, 30342
    • Illinois
      • Chicago, Illinois, United States, 60607
    • Indiana
      • Avon, Indiana, United States, 46123
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
    • Maine
      • Bangor, Maine, United States, 04401
    • Michigan
      • Royal Oak, Michigan, United States, 48073
    • Mississippi
      • Picayune, Mississippi, United States, 39466
    • New Jersey
      • Clifton, New Jersey, United States, 07012
      • Toms River, New Jersey, United States, 08753
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
    • New York
      • New York, New York, United States, 10025
      • Springfield Gardens, New York, United States, 11413
    • North Carolina
      • Charlotte, North Carolina, United States, 28277
      • Shelby, North Carolina, United States, 28150
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
    • Oregon
      • Medford, Oregon, United States, 97504
    • South Carolina
      • Clinton, South Carolina, United States, 29325
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
    • Texas
      • Dallas, Texas, United States, 75246
      • Houston, Texas, United States, 77074
      • Midland, Texas, United States, 79707
      • San Antonio, Texas, United States, 78237

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: placebo
sc once weekly
Experimental: taspoglutide
Drug: taspoglutide
10mg sc once weekly for 4 weeks, then 20mg sc once weekly

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Absolute change from baseline in HbA1c
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in body weight;% of patients achieving >=5% weight loss
Time Frame: 24 weeks
24 weeks
% of patients achieving target HbA1c <=6.5%, <=7.0%; change from baseline in fasting plasma glucose; change from baseline in lipid profile; relative change in glucose, insulin, C-peptide and glucagon during a meal tolerance test; beta cell function
Time Frame: 24 weeks
24 weeks
Safety:Adverse events,clinical laboratory tests, vital signs,physical examination, ECG, anti-taspoglutide antibodies\n
Time Frame: At planned clinic visits, for 12 months
At planned clinic visits, for 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

January 15, 2009

First Submitted That Met QC Criteria

January 15, 2009

First Posted (Estimate)

January 16, 2009

Study Record Updates

Last Update Posted (Estimate)

July 28, 2016

Last Update Submitted That Met QC Criteria

July 26, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BC22092
  • 2008-005809-20

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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