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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00823992
First received: January 15, 2009
Last updated: September 22, 2014
Last verified: September 2014
  Purpose

This 2 arm study will assess the efficacy, safety and tolerability of taspogluti de compared to placebo in obese patients with type 2 diabetes mellitus inadequat ely controlled with metformin monotherapy. Patients will be randomized to receiv e 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.Aft er 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 ti me on study treatment is 12 months, and the target sample size is 100-500 indivi duals.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: placebo
Drug: taspoglutide
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Absolute change from baseline in HbA1c [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in body weight;% of patients achieving >=5% weight loss [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • % 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 ] [ Designated as safety issue: No ]
  • Safety:Adverse events,clinical laboratory tests, vital signs,physical examination, ECG, anti-taspoglutide antibodies\n [ Time Frame: At planned clinic visits, for 12 months ] [ Designated as safety issue: No ]

Enrollment: 305
Study Start Date: January 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: taspoglutide
10mg sc once weekly for 4 weeks, then 20mg sc once weekly
Placebo Comparator: 2 Drug: placebo
sc once weekly

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00823992

  Hide Study Locations
Locations
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
United States, Florida
Brooksville, Florida, United States, 34601
Miami, Florida, United States, 33133
St. Petersburg, Florida, United States, 33709
United States, Georgia
Atlanta, Georgia, United States, 30342
United States, Illinois
Chicago, Illinois, United States, 60607
United States, Indiana
Avon, Indiana, United States, 46123
United States, Louisiana
New Orleans, Louisiana, United States, 70121
United States, Maine
Bangor, Maine, United States, 04401
United States, Michigan
Royal Oak, Michigan, United States, 48073
United States, Mississippi
Picayune, Mississippi, United States, 39466
United States, New Jersey
Clifton, New Jersey, United States, 07012
Toms River, New Jersey, United States, 08753
United States, New Mexico
Albuquerque, New Mexico, United States, 87131
United States, New York
New York, New York, United States, 10025
Springfield Gardens, New York, United States, 11413
United States, North Carolina
Charlotte, North Carolina, United States, 28277
Shelby, North Carolina, United States, 28150
United States, Oklahoma
Norman, Oklahoma, United States, 73069
United States, Oregon
Medford, Oregon, United States, 97504
United States, South Carolina
Clinton, South Carolina, United States, 29325
United States, Tennessee
Kingsport, Tennessee, United States, 37660
United States, Texas
Dallas, Texas, United States, 75246
Houston, Texas, United States, 77074
Midland, Texas, United States, 79707
San Antonio, Texas, United States, 78237
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 1L8
Canada, Nova Scotia
Sherbrooke, Nova Scotia, Canada, J1G 2E8
Canada, 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, 115280
Moscow, Russian Federation, 117036
Moscow, Russian Federation, 105229
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
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00823992     History of Changes
Other Study ID Numbers: BC22092, 2008-005809-20
Study First Received: January 15, 2009
Last Updated: September 22, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 01, 2014