A Study of Taspoglutide Versus Pioglitazone in Patients With Type 2 Diabetes

November 1, 2016 updated by: Hoffmann-La Roche

A Multicenter, Randomized, Double Blind (Double Dummy), Active Controlled Study to Compare the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Pioglitazone in Type 2 Diabetes Patients Inadequately Controlled on Therapy With Sulfonylurea or Metformin Plus Sulfonylurea

This double-blind, double-dummy 3 arm study will evaluate the efficacy, safety and tolerability of taspoglutide versus pioglitazone in patients with type 2 diabetes mellitus inadequately controlled with sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy. After an initial screening period, patients will be randomized to one of 3 groups, to receive a)taspoglutide 10mg sc weekly, b)taspoglutide 20mg sc weekly after 4 weeks of taspoglutide 10mg sc weekly or c)pioglitazone 45mg/day po after 4 weeks of pioglitazone 30mg/day po.The anticipated time on study treatment is 24 months, and the target sample size is 500+ individuals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

756

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

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
      • Wollongong, New South Wales, Australia, 2500
  • Brazil
    • CE
      • Fortaleza, CE, Brazil, 60430-370
    • DF
      • Lago sul, DF, Brazil, 71625009
    • MG
      • Belo Horizonte, MG, Brazil, 30150-221
    • SP
      • Marilia, SP, Brazil, 17519030
      • Sao Paulo, SP, Brazil, 01221-020
      • Sao Paulo, SP, Brazil, 01244-030
      • Sao Paulo, SP, Brazil, 04022-001
      • Sao Paulo, SP, Brazil, 04020-050
      • Sorocaba, SP, Brazil, 18047-360
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3X8
    • Ontario
      • Etobicoke, Ontario, Canada, M9R 4E1
      • London, Ontario, Canada, N6A 5R8
      • Thornhill, Ontario, Canada, L4J 8L7
      • Toronto, Ontario, Canada, M9W 4L6
      • Toronto, Ontario, Canada, M4G 3E8
  • Costa Rica
      • San Jose, Costa Rica, 755-1000
      • San Jose, Costa Rica, 4395-1000
  • France
      • Besancon, France, 25030
      • Corbeil Essonnes, France, 91106
      • Dommartin Les Toul, France, 54200
      • La Rochelle, France, 17019
      • Lille, France, 59037
      • Poitiers, France, 86021
      • Venissieux, France, 69200
  • Germany
      • Berlin, Germany, 10115
      • Essen, Germany, 45359
      • Falkensee, Germany, 14612
      • Mainz, Germany, 55116
      • Münster, Germany, 48145
      • Rodgau, Germany, 63110
      • Siegen, Germany, 57074
      • Sulzbach-Rosenberg, Germany, 92237
      • Wangen, Germany, 88239
  • Mexico
      • Aguascaliente, Mexico, 20230
      • Celaya, Mexico, 38000
      • Cuernavaca, Mexico, 62250
      • Guadalajara, Mexico, 44650
      • Guadalajara, Mexico, 44100
      • Mexico-City, Mexico, 06700
      • Monterrey, Mexico, 64460
  • New Zealand
      • Auckland, New Zealand
      • Auckland, New Zealand, 1640
  • Peru
      • San Isidro, Peru, 27
  • Poland
      • Gdansk, Poland, 80-858
      • Krakow, Poland, 30-015
      • Krakow, Poland, 31-455
      • Lublin, Poland, 20-044
      • Lublin, Poland, 20-538
      • Wroclaw, Poland, 50-044
  • Puerto Rico
      • Rio Piedras, Puerto Rico, 00926
  • Russian Federation
      • Moscow, Russian Federation, 127299
      • Moscow, Russian Federation, 117036
      • Moscow, Russian Federation, 121069
      • Penza, Russian Federation, 440026
      • S.Petersburg, Russian Federation, 194017
      • Saint-Petersburg, Russian Federation, 194156
      • Saint-Petersburg, Russian Federation, 197022
      • Saint-Petersburg, Russian Federation, 195057
      • Saratov, Russian Federation, 140018
      • St. Petersburg, Russian Federation, 194354
      • St. Petersburg, Russian Federation, 193012
      • Voronezh, Russian Federation, 394018
      • Yaroslavl, Russian Federation, 150062
      • Yaroslavl, Russian Federation, 150023
  • Slovakia
      • Bratislava, Slovakia, 851 01
      • Dolny Kubin, Slovakia, 026 01
      • Levice, Slovakia, 93405
      • Levice, Slovakia, 034 01
  • South Africa
      • Cape Town, South Africa, 7130
  • Spain
      • Almeria, Spain, 04001
      • Barcelona, Spain, 08907
    • Asturias
      • Oviedo, Asturias, Spain, 33006
    • Navarra
      • Pamplona, Navarra, Spain, 31008
    • Vizcaya
      • Barakaldo, Vizcaya, Spain, 48903
  • Thailand
      • Chiang Mai, Thailand, 50200
      • Pathumthani, Thailand, 12120
      • Songkla, Thailand, 90112
  • Ukraine
      • Kiev, Ukraine, 04050
      • Odessa, Ukraine, 65009
      • Odessa, Ukraine, 65117
      • Vinnitsa, Ukraine, 21010
  • United Kingdom
      • Atherstone, United Kingdom, CV9 1EU
      • Birmingham, United Kingdom, B9 5SS
      • Chesterfield, United Kingdom, S40 4TF
      • Dumfries, United Kingdom, DG1 4AP
      • Glasgow, United Kingdom, G45 9AW
      • Hinckley, United Kingdom, LE10 2SE
      • Reading, United Kingdom, RG7 3SQ
  • United States
    • California
      • Buena Park, California, United States, 90620
      • Chino, California, United States, 91710
      • Los Angeles, California, United States, 90057
      • Rancho Cucamonga, California, United States, 91730
      • Roseville, California, United States, 95661
      • Santa Ana, California, United States, 92701
    • Florida
      • Chiefland, Florida, United States, 32626
      • Coral Gables, Florida, United States, 33134
      • Daytona Beach, Florida, United States, 32117
      • Panama City, Florida, United States, 32401
      • Port Charlotte, Florida, United States, 33948
      • St Petersburg, Florida, United States, 33716
      • Winter Park, Florida, United States, 32789
    • Georgia
      • Atlanta, Georgia, United States, 30338
      • Columbus, Georgia, United States, 31904
      • Conyers, Georgia, United States, 30094
      • Roswell, Georgia, United States, 30076
    • Illinois
      • Chicago, Illinois, United States, 60607
      • Chicago, Illinois, United States, 60610-4319
      • Springfield, Illinois, United States, 62704-1433
    • Indiana
      • Evansville, Indiana, United States, 47714
    • Kentucky
      • Madisonville, Kentucky, United States, 42431
    • Louisiana
      • Metairie, Louisiana, United States, 70006
    • Maryland
      • Bethesda, Maryland, United States, 20817
    • Massachusetts
      • Ayer, Massachusetts, United States, 01432
      • Waltham, Massachusetts, United States, 02453
    • Michigan
      • Ferndale, Michigan, United States, 48220
    • Minnesota
      • Minneapolis, Minnesota, United States, 55416
    • Mississippi
      • Biloxi, Mississippi, United States, 39531
      • Jackson, Mississippi, United States, 39216
      • Olive Branch, Mississippi, United States, 38654
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
    • New Jersey
      • Berlin, New Jersey, United States, 08009
      • Brick, New Jersey, United States, 08724
      • Toms River, New Jersey, United States, 08753
      • Trenton, New Jersey, United States, 08611
    • New York
      • New York, New York, United States, 10021
      • Staten Island, New York, United States, 10301
    • North Carolina
      • Durham, North Carolina, United States, 27713
      • Mooresville, North Carolina, United States, 28117
      • Winston-salem, North Carolina, United States, 27103
    • North Dakota
      • Fargo, North Dakota, United States, 58103
    • Oregon
      • Bend, Oregon, United States, 97701
      • Medford, Oregon, United States, 97504
    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15009
      • Philadelphia, Pennsylvania, United States, 19107
      • Scranton, Pennsylvania, United States, 18510
    • Tennessee
      • Kingsport, Tennessee, United States, 37660
    • Texas
      • Dallas, Texas, United States, 75230
      • Houston, Texas, United States, 77074
    • Utah
      • Salt Lake City, Utah, United States, 84107
    • Vermont
      • South Burlington, Vermont, United States, 05403
    • Virginia
      • Richmond, Virginia, United States, 23249
      • Richmond, Virginia, United States, 23226
    • Washington
      • Spokane, Washington, United States, 99202
      • Vancouver, Washington, United States, 98664
    • Wisconsin
      • Waukesha, Wisconsin, United States, 53189

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;
  • treated with stable sulfonylurea monotherapy or metformin + sulfonylurea for >=12 weeks prior to screening;
  • HbA1c >=7.0% and <=10% at screening;
  • stable weight +/-5% for >=12 weeks prior to screening.

Exclusion Criteria:

  • type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes;
  • clinically significant diabetic complications;
  • clinically symptomatic gastrointestinal disease;
  • >3 episodes of severe hypoglycemia within 6 months before screening.

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
Active Comparator: pioglitazone
Drug: pioglitazone
30mg po once daily for 4 weeks, followed by 45mg once daily
Experimental: taspoglutide 10mg
taspoglutide 10mg sc weekly
Drug: taspoglutide
10mg sc once weekly
Drug: taspoglutide
10mg sc once weekly for 4 weeks, followed by 20 mg sc once weekly
Experimental: taspoglutide 10mg/20mg
taspoglutide 20mg sc weekly after 4 weeks of taspoglutide 10mg sc weekly
Drug: taspoglutide
10mg sc once weekly
Drug: taspoglutide
10mg sc once weekly for 4 weeks, followed by 20 mg 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
Proportion of patients achieving target HbA1c <=6.5%, <=7%
Time Frame: weeks 24, 52 and 104
weeks 24, 52 and 104
Absolute/percentage change from baseline in body weight; responder rate for body weight; absolute/percentage change from baseline in waist and hip circumference;absolute/percentage change from baseline in fasting plasma glucose
Time Frame: weeks 24, 52 and 104
weeks 24, 52 and 104
Adverse events; laboratory parameters; cardiovascular events
Time Frame: At each clinic visit up to 106 weeks
At each clinic visit up to 106 weeks

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

May 1, 2009

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

May 27, 2009

First Submitted That Met QC Criteria

May 27, 2009

First Posted (Estimate)

May 28, 2009

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BC21893
  • 2009-009157-24

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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