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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus Type 2
• Intervention / Treatment: Drug: metformin; Drug: pioglitazone; Drug: placebo; Drug: taspoglutide; Drug: taspoglutide

• Study Type: Interventional
• Enrollment (Actual): 326
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Brasilia, Brazil, 70390-155
  • Forlateza, Brazil, 60430-350
  • Fortaleza, Brazil, 60155-290
  • Fortaleza, Brazil, 60430-370
  • Fortaleza, Brazil, 60120-021
  • Mogi Das Cruzes - Sp, Brazil, 08780-090
  • Passo Fundo, Brazil, 99010-901
  • Porto Alegre, Brazil, 90035-001
  • Recife, Brazil, 50100-130
  • Sao Paulo, Brazil, 05403-000
  • Sao Paulo, Brazil, 01244-030
  • Sao Paulo, Brazil, 01221-020
  • Sao Paulo, Brazil, 04022-001
• Canada
  • Newfoundland and Labrador
    • Mount Pearl, Newfoundland and Labrador, Canada, A1N 1W7
  • Ontario
    • Hamilton, Ontario, Canada, L8N 3Z5
    • London, Ontario, Canada, N6A 5R8
    • Toronto, Ontario, Canada, M9W 4L6
  • Quebec
    • Montreal, Quebec, Canada, H2W 1T8
    • Pointe-claire, Quebec, Canada, H9R 4S3
• Costa Rica
  • San Jose, Costa Rica, 755-1000
• France
  • Bondy, France, 93143
  • Dijon, France, 21079
  • Nantes, France, 44093
  • Narbonne, France, 11108
• Germany
  • Falkensee, Germany, 14612
  • Karlsruhe, Germany, 76199
  • Mainz, Germany, 55116
  • Neuwied, Germany, 56564
  • Potsdam, Germany, 14469
• Guatemala
  • Guatemala, Guatemala
  • Guatemala, Guatemala, 01010
• Mexico
  • Chihuahua, Mexico, 31238
  • Jalisco, Mexico, 44690
  • Mexico City, Mexico, 11650
• Puerto Rico
  • Carolina, Puerto Rico, 00983
  • Guyanabo, San Juan, Puerto Rico, 00920
  • San Juan, Puerto Rico, 00926-2832
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
    • Birmingham, Alabama, United States, 35209
    • Huntsville, Alabama, United States, 35801
    • Muscle Shoals, Alabama, United States, 35661
  • Arizona
    • Phoenix, Arizona, United States, 85032
    • Phoenix, Arizona, United States, 85028
  • California
    • Buena Park, California, United States, 90620
    • Lancaster, California, United States, 93534
    • Loma Linda, California, United States, 92354
    • Rancho Cucamonga, California, United States, 91730
    • Roseville, California, United States, 95661
    • San Diego, California, United States, 92161
    • Walnut Creek, California, United States, 94598
  • Colorado
    • Wheatridge, Colorado, United States, 80033
  • Connecticut
    • Hamden, Connecticut, United States, 06518
  • District of Columbia
    • Washington, District of Columbia, United States, 20017
  • Florida
    • Bradenton, Florida, United States, 34208
    • Chiefland, Florida, United States, 32626
    • Fort Myers, Florida, United States, 33907
    • Gainesville, Florida, United States, 32607
    • Hollywood, Florida, United States, 33021
    • Miami, Florida, United States, 33136
    • New Port Richey, Florida, United States, 34652
    • Ocala, Florida, United States, 34474
    • Plantation, Florida, United States, 33317
    • Tampa, Florida, United States, 33614
  • Idaho
    • Nampa, Idaho, United States, 83687
  • Illinois
    • Aurora, Illinois, United States, 60504
    • Libertyville, Illinois, United States, 60048
  • Indiana
    • Evansville, Indiana, United States, 47714
  • Iowa
    • Des Moines, Iowa, United States, 50314
  • Kansas
    • Topeka, Kansas, United States, 66614
  • Kentucky
    • Lexington, Kentucky, United States, 40504
    • Madisonville, Kentucky, United States, 42431
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
  • Maryland
    • Frederick, Maryland, United States, 21702
    • Oxon Hill, Maryland, United States, 20745
  • Michigan
    • Detroit, Michigan, United States, 48202
    • Ferndale, Michigan, United States, 48220
    • Kalamazoo, Michigan, United States, 49048
  • Mississippi
    • Biloxi, Mississippi, United States, 39531
    • Olive Branch, Mississippi, United States, 38654
  • Missouri
    • St Peters, Missouri, United States, 63376
  • Nebraska
    • Omaha, Nebraska, United States, 68114
    • Omaha, Nebraska, United States, 68131
  • Nevada
    • Las Vegas, Nevada, United States, 89148
  • New York
    • Albany, New York, United States, 12206-1098
    • Brooklyn, New York, United States, 11218
    • Hudson, New York, United States, 12534
    • Lake Success, New York, United States, 11042
    • Staten Island, New York, United States, 10301
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
    • Charlotte, North Carolina, United States, 28262
    • Mooresville, North Carolina, United States, 28117
    • Wilmington, North Carolina, United States, 28401
  • North Dakota
    • Bismarck, North Dakota, United States, 58501
  • Ohio
    • Athens, Ohio, United States, 45701
    • Cincinnati, Ohio, United States, 45219
    • Kettering, Ohio, United States, 45429
  • Oklahoma
    • Norman, Oklahoma, United States, 73071
  • Oregon
    • Medford, Oregon, United States, 97504
  • Pennsylvania
    • Beaver, Pennsylvania, United States, 15009
    • Bensalem, Pennsylvania, United States, 19020
    • Carlisle, Pennsylvania, United States, 17015
    • Levittown, Pennsylvania, United States, 19056
    • Melrose Park, Pennsylvania, United States, 19027
    • Pittsburgh, Pennsylvania, United States, 15236
  • Rhode Island
    • Cranston, Rhode Island, United States, 02920
  • South Carolina
    • Greer, South Carolina, United States, 29651
  • Texas
    • Bellaire, Texas, United States, 77401
    • Dallas, Texas, United States, 75231
    • Dallas, Texas, United States, 75230
    • Houston, Texas, United States, 77030
    • San Antonio, Texas, United States, 78205
  • Utah
    • Salt Lake City, Utah, United States, 84102
  • Washington
    • Federal Way, Washington, United States, 98003

Participation Criteria

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 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo in addition to 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.	Drug: metformin; >1500 mg/day or maximum tolerated dose (MTD); Drug: pioglitazone; >= 30 mg/day; Drug: placebo; sc once weekly; Drug: taspoglutide; 10 mg sc once weekly; Drug: taspoglutide; 20 mg sc once weekly (after 4 weeks of taspoglutide 10 mg sc once weekly)
Experimental: Taspoglutide 10mg; Taspoglutide 10mg once weekly in addition to continued stable metformin plus pioglitazone treatment	Drug: metformin; >1500 mg/day or maximum tolerated dose (MTD); Drug: pioglitazone; >= 30 mg/day; Drug: taspoglutide; 10 mg sc once weekly; Drug: taspoglutide; 20 mg sc once weekly (after 4 weeks of taspoglutide 10 mg sc once weekly)
Experimental: Taspoglutide 10mg/20mg; Taspoglutide 20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly) in addition to continued stable metformin plus pioglitazone treatment.	Drug: metformin; >1500 mg/day or maximum tolerated dose (MTD); Drug: pioglitazone; >= 30 mg/day; Drug: taspoglutide; 10 mg sc once weekly; Drug: taspoglutide; 20 mg sc once weekly (after 4 weeks of taspoglutide 10 mg sc once weekly)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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.	24 weeks
Safety: adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies.	Throughout the study

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: August 29, 2008
• First Submitted That Met QC Criteria: August 29, 2008
• First Posted (Estimate): September 1, 2008

Study Record Updates

• Last Update Posted (Estimate): August 5, 2016
• Last Update Submitted That Met QC Criteria: August 3, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Incretins; Metformin; Pioglitazone; Glucagon-Like Peptide 1
• Other Study ID Numbers: BC20963; 2008-001744-39