A Study of Taspoglutide Versus Exenatide for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin, Thiazolidinedione or a Combination of Both.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00717457
Recruitment Status : Completed
First Posted : July 17, 2008
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This 3-arm study will assess the efficacy, safety and tolerability of taspoglutide compared with exenatide in patients with type 2 diabetes mellitus inadequately controlled with metformin, thiazolidinedione or a combination of both. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly) or exenatide (5 micrograms twice daily for 4 weeks followed by 10 micrograms twice daily) in a ratio of 1:1:1 in addition to continued prestudy metformin and thiazolidinedione either alone or in combination. The anticipated time on study treatment is 3+ years, and the target sample size is >500 individuals.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 2 Drug: exenatide Drug: taspoglutide Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1189 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized, Active Controlled, Open Label Study to Compare Taspoglutide vs Exenatide as add-on Treatment to Metformin and/or Thiazolidinediones in Patients With Type 2 Diabetes Mellitus
Study Start Date : July 2008
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide

Arm Intervention/treatment
Active Comparator: exenatide Drug: exenatide
5mg twice daily for 4 weeks followed by 10mg twice daily

Experimental: taspoglutide 10mg Drug: taspoglutide
10mg once weekly

Experimental: taspoglutide 10mg/20mg Drug: taspoglutide
10mg once weekly for 4 weeks followed by 20mg once weekly

Primary Outcome Measures :
  1. Change in HbA1c [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Fasting body weight [ Time Frame: 24 weeks ]
  2. Proportion of patients reaching target HbA1c <=7.0%, <=6.5% [ Time Frame: 24 weeks ]
  3. Relative change in glucose, insulin, C-peptide and glucagon values during a meal tolerance test in a subset of patients. [ Time Frame: 24 weeks ]
  4. Beta cell function (proinsulin/insulin ratio) [ Time Frame: 24 weeks ]

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • adult patients, 18-75 years of age;
  • type 2 diabetes receiving metformin and/or pioglitazone or rosiglitazone for at least 12 weeks;
  • HbA1c >=7.0% and <=10% at screening;
  • BMI >=25kg/m2 (>23kg/m2 for Asians) and <=45kg/m2 at screening;
  • stable weight +/- 5% for at least 12 weeks prior to screening.

Exclusion Criteria:

  • history of type 1 diabetes, diabetes resulting from pancreatic injury or secondary forms of diabetes;
  • history of acute metabolic diabetic complications within the previous 6 months;
  • evidence of clinically significant diabetic complications;
  • known proliferative diabetic retinopathy;
  • myocardial infarction (MI), coronary artery bypass surgery, post-transplantation cardiomyopathy (PTCM) or stroke within the past 6 months;
  • any abnormality in clinical laboratory test or ECG, which precludes safe involvement in the study as judged by the investigator;
  • known hemoglobinopathy or chronic anemia;
  • clinically significant gastrointestinal disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00717457

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United States, Alabama
Haleyville, Alabama, United States, 35565
Mobile, Alabama, United States, 36617
Montgomery, Alabama, United States, 36106
Tuscaloosa, Alabama, United States, 35406
United States, Arkansas
Little Rock, Arkansas, United States, 72204
United States, California
Escondido, California, United States, 92026
La Jolla, California, United States, 92037
Mission Viejo, California, United States, 92691
Orange, California, United States, 92868
Palm Springs, California, United States, 92262
Rancho Cucamonga, California, United States, 91730
Sacramento, California, United States, 95816-5119
San Leandro, California, United States, 94578
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Colorado Springs, Colorado, United States, 80904
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Daytona Beach, Florida, United States, 32114
Ft. Lauderdale, Florida, United States, 33316
Green Cove Springs, Florida, United States, 32043
Jacksonville, Florida, United States, 32216
Miami Beach, Florida, United States, 33140
Niceville, Florida, United States, 32578
Orlando, Florida, United States, 32804
United States, Georgia
Atlanta, Georgia, United States, 30308
Atlanta, Georgia, United States, 30318
Suwanee, Georgia, United States, 30024
United States, Illinois
Chicago, Illinois, United States, 60607
Chicago, Illinois, United States, 60622
Lombard, Illinois, United States, 60148
Peoria, Illinois, United States, 61625
United States, Indiana
Evansville, Indiana, United States, 47714
New Albany, Indiana, United States, 47150
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Iowa City, Iowa, United States, 52242
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Munfordville, Kentucky, United States, 42765
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Metairie, Louisiana, United States, 70006
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Bangor, Maine, United States, 04401
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Baltimore, Maryland, United States, 21209
Bethesda, Maryland, United States, 20817
Rockville, Maryland, United States, 20854
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Royal Oak, Michigan, United States, 48073
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Jefferson City, Missouri, United States, 65109
Kansas City, Missouri, United States, 64111
Saint Louis, Missouri, United States, 63117
Saint Louis, Missouri, United States, 63141
Washington, Missouri, United States, 63090
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Omaha, Nebraska, United States, 68114
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Concord, New Hampshire, United States, 03301
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Trenton, New Jersey, United States, 08611
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Whitehouse, New Jersey, United States, 08889
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Brooklyn, New York, United States, 11203
New York, New York, United States, 10025
Rochester, New York, United States, 14607
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Syracuse, New York, United States, 13210
West Seneca, New York, United States, 14224
Westfield, New York, United States, 14787
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Charlotte, North Carolina, United States, 28209
Charlotte, North Carolina, United States, 28233
Durham, North Carolina, United States, 27713
Greensboro, North Carolina, United States, 27408
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Salisbury, North Carolina, United States, 28144
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Fargo, North Dakota, United States, 58103
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Cincinnati, Ohio, United States, 45236
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Medford, Oregon, United States, 97504
Portland, Oregon, United States, 97239
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Altoona, Pennsylvania, United States, 16602
Norristown, Pennsylvania, United States, 19401
Philadelphia, Pennsylvania, United States, 19107
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Providence, Rhode Island, United States, 02908
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Clemson, South Carolina, United States, 29631
Columbia, South Carolina, United States, 29201
Hickory, South Carolina, United States, 28602
Simpsonville, South Carolina, United States, 29681
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Bristol, Tennessee, United States, 37620
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Austin, Texas, United States, 78705
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Houston, Texas, United States, 77005
Houston, Texas, United States, 77024
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Richmond, Virginia, United States, 23226
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Everett, Washington, United States, 98201
Buenos Aires, Argentina, 6000
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Australia, New South Wales
Camperdown, New South Wales, Australia, 2050
Australia, Queensland
Freemantle, Queensland, Australia, 6959
Goiania, GO, Brazil, 74043011
Belem, PA, Brazil, 66073-000
Curtiba, PR, Brazil, 80030-110
Porto Alegre, RS, Brazil, 90035-170
Mogi Das Cruzes - Sp, SP, Brazil, 08780-090
Sao Paulo, SP, Brazil, 01221-020
Sao Paulo, SP, Brazil, 04022-001
Canada, British Columbia
Vancouver, British Columbia, Canada, V5Z 1L8
Canada, Ontario
London, Ontario, Canada, N6A 5R8
Toronto, Ontario, Canada, M5C 2T2
Canada, Quebec
Pointe-Claire, Quebec, Canada, H9R 4S3
Ballerup, Denmark, 2750
Helsinki, Finland, 00150
Kuopio, Finland, 70210
Oulu, Finland, 90100
Turku, Finland, 20100
Corbeil Essonnes, France, 91106
Dommartin Les Toul, France, 54200
Montpellier, France, 34295
Narbonne, France, 11108
Paris, France, 75475
Salouel, France, 80480
Aschaffenburg, Germany, 63739
Berlin, Germany, 10115
Damme, Germany, 49401
Dresden, Germany, 01219
Essen, Germany, 45359
Falkensee, Germany, 14612
Hamburg, Germany, 21073
Hamburg, Germany, 22607
Ludwigshafen, Germany, 67059
Mainz, Germany, 55116
München, Germany, 80634
Münster, Germany, 48145
Neuwied, Germany, 56564
Nürnberg, Germany, 90402
Pirna, Germany, 01796
Rhaunen, Germany, 55624
Villingen-Schwenningen, Germany, 78048
Zwenkau, Germany, 04442
Thessaloniki, Greece, 56429
Thessaloniki, Greece, 57010
Guatemala, Guatemala, 01000
Guatemala, Guatemala, 01014
Beer Sheva, Israel, 8410101
Haifa, Israel, 31096
Holon, Israel, 58100
Jerusalem, Israel, 91200
Kfar Saba, Israel, 44281
Petach Tikva, Israel, 49100
Ramat Gan, Israel, 52621
Tel Aviv, Israel, 64239
Pordenone, Friuli-Venezia Giulia, Italy, 33170
Genova, Liguria, Italy, 16132
Pavia, Lombardia, Italy, 27100
Olbia, Sardegna, Italy, 07026
Siena, Toscana, Italy, 53100
Korea, Republic of
Seoul, Korea, Republic of, 0
Seoul, Korea, Republic of, 110-744
Acapulco, Mexico, 39670
Aguascalientes, Mexico, 20127
Chihuahua, Mexico, 31205
Durango, Mexico, 34000
Guadalajara, Mexico, 44600
Guadalajara, Mexico, 44650
Monterrey, Mexico, 64460
Monterrey, Mexico, 64700
Tampico, Mexico, 89000
New Zealand
Auckland, New Zealand, 1640
Auckland, New Zealand
Arequipa, Peru, Cercado
Lima, Peru, 41
Lima, Peru, Lima 33
Puerto Rico
Ponce, Puerto Rico, 00716
Ponce, Puerto Rico, 00717-322
Russian Federation
Barnaul, Russian Federation, 656024
Moscow, Russian Federation, 109263
Moscow, Russian Federation, 119048
Moscow, Russian Federation, 119121
Moscow, Russian Federation, 121069
Moscow, Russian Federation, 125299
Moscow, Russian Federation, 125315
Moscow, Russian Federation, 129110
Nizhny Novgorod, Russian Federation, 603126
Novosibirsk, Russian Federation, 630047
Novosibirsk, Russian Federation, 630091
Omsk, Russian Federation, 644021
S. Petersburg, Russian Federation, 194291
S.Petersburg, Russian Federation, 194017
Saint-Petersburg, Russian Federation, 197022
Saratov, Russian Federation, 140018
St Petersburg, Russian Federation, 195213
St-Petersburg, Russian Federation, 194291
St. Petersburg, Russian Federation, 191124
St. Petersburg, Russian Federation, 193012
St. Petersburg, Russian Federation, 194354
Tomsk, Russian Federation, 643050
Yaroslavl, Russian Federation, 150010
Yaroslavl, Russian Federation, 150062
South Africa
Cape Town, South Africa, 7130
Pretoria, South Africa, 0002
Bacarot Alicant, Alicante, Spain, 03114
Alzira, Valencia, Spain, 46600
Almeria, Spain, 04001
Madrid, Spain, 28041
Karlstad, Sweden, 65185
Stockholm, Sweden, 171 76
Uppsala, Sweden, 75185
Örebro, Sweden, 701 85
Zürich, Switzerland, 8091
Bangkok, Thailand, 10330
Bangkok, Thailand, 10400
Dnipropetrovs'k, Ukraine, 49044
Donetsk, Ukraine, 83003
Kiev, Ukraine, 02091
Lviv, Ukraine, 79010
Odessa, Ukraine, 65009
Odessa, Ukraine, 65117
Simferopol, Ukraine, 95017
United Kingdom
Bath, United Kingdom, BA1 2SR
Bradford on Avon, United Kingdom, BA15 1DQ
Glasgow, United Kingdom, G45 9AW
Lanarkshire, United Kingdom, ML1 3JX
Trowbridge, United Kingdom, BA14 8QA
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche Identifier: NCT00717457     History of Changes
Other Study ID Numbers: BC21625
First Posted: July 17, 2008    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists