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

A Multicenter, Randomized, Double-dummy, Placebo and Active-controlled Study to Assess the Safety, Tolerability and Effect of Taspoglutide on Glycemic Control Compared to Sitagliptin and Placebo in Patients With Type II Diabetes Mellitus Inadequately Controlled With Metformin.

This 4 arm study will assess the efficacy, safety and tolerability of taspoglutide compared to sitagliptin and placebo in patients with type 2 diabetes mellitus inadequately controlled with metformin. Patients will be randomized to receive taspoglutide (10mg once weekly or 10mg once weekly for 4 weeks followed by 20mg once weekly), sitagliptin 100mg once daily or placebo, in a ratio of 2:2:2:1, in addition to their continued prestudy metformin treatment. After 24 weeks of treatment, patients on active treatment will continue on the same treatment and 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 2+ years, and the target sample size is 500+ individuals.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus Type 2
• Intervention / Treatment: Drug: Metformin; Drug: Placebo (matching sitagliptin); Drug: Placebo (matching taspoglutide); Drug: Sitagliptin; Drug: Taspoglutide

• Study Type: Interventional
• Enrollment (Actual): 666
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1012
  • Buenos Aires, Argentina, C1213AAH
  • Mar del Plata, Argentina, B7600DHK
• Australia
  • Queensland
    • Freemantle, Queensland, Australia, 6959
  • South Australia
    • Adelaide, South Australia, Australia, 5000
• Canada
  • Ontario
    • London, Ontario, Canada, N6A 4V2
    • Thornhill, Ontario, Canada, L4J 8L7
    • Toronto, Ontario, Canada, M9W 4L6
  • Quebec
    • Montreal, Quebec, Canada, H2W 1T8
    • Pointe-Claire, Quebec, Canada, H9R 4S3
• France
  • Bondy, France, 93143
  • Nantes, France, 44093
  • Poitiers, France, 86021
  • Rennes, France, 35203
  • St Mande, France, 94163
• Germany
  • Berlin, Germany, 10115
  • Dormagen, Germany, 41539
  • Dresden, Germany, 01307
  • Kiel Kronshagen, Germany, 24119
  • Muenchen, Germany, 80336
  • Sulzbach-Rosenberg, Germany, 92237
  • Villingen-Schwenningen, Germany, 78048
• Greece
  • Larissa, Greece, 41110
• Korea, Republic of
  • Gyeonggi-do, Korea, Republic of, 443-380
  • Gyeonggi-do, Korea, Republic of
  • Seoul, Korea, Republic of
  • Seoul, Korea, Republic of, 152-703
  • Wonju, Korea, Republic of, 220-701
• Mexico
  • Cuernavaca, Mexico, 62250
  • Hermosillo, Mexico, 83200
  • Jalisco, Mexico, 44690
  • Mexico City, Mexico, 06700
  • Mexico City, Mexico, 11520
  • Monterrey, Mexico, 64000
  • Pachuca, Mexico, 42086
• Norway
  • Elverum, Norway, 2401
  • Oslo, Norway, 0027
  • Oslo, Norway, 0176
  • Oslo, Norway, 0407
• Peru
  • Lima, Peru, Lima 33
  • Lima, Peru, Lima 9
• Poland
  • Bialystok, Poland, 15-445
  • Gdansk, Poland, 80-858
  • Kamieniec Zabkowicki, Poland, 57-230
  • Rzeszow, Poland, 35-073
  • Skierniewice, Poland, 96-100
  • Sobótka, Poland, 55-050
  • Wroclaw, Poland, 51-124
• Puerto Rico
  • Caguas, Puerto Rico, 00725
  • Carolina, Puerto Rico, 00983
• Romania
  • Bucuresti, Romania, 020359
  • Buzau, Romania, 120203
  • Cluj-napoca, Romania, 400006
  • Ploiesti, Romania, 100163
  • Ploiesti, Romania, 100342
• Slovakia
  • Levice, Slovakia, 93405
  • Presov, Slovakia, 080 01
  • Samorin, Slovakia, 931 01
  • Trebisov, Slovakia, 07501
  • Trencin, Slovakia, 911 01
• South Africa
  • Cape Town, South Africa, 7130
  • Pretoria, South Africa, 0002
• Spain
  • Almeria, Spain, 04001
  • Sevilla, Spain, 41010
  • Valencia, Spain, 46014
  • Alicante
    • Bacarot Alicant, Alicante, Spain, 03114
• Sweden
  • Ljungby, Sweden, 34182
  • Stockholm, Sweden, 14186
  • Örebro, Sweden, 701 85
• Switzerland
  • Basel, Switzerland, 4031
  • Geneve, Switzerland, 1211
  • Zürich, Switzerland, 8063
• Taiwan
  • Taichung, Taiwan, 407
  • Taipei, Taiwan, 114
  • Taipei, Taiwan, 220
  • Taoyuan County, Taiwan, 333
• Thailand
  • Bangkok, Thailand, 10330
  • Songkla, Thailand, 90112
• Turkey
  • Istanbul, Turkey, 34390
• United Kingdom
  • Bexhill on Sea, United Kingdom, TN39 4SP
  • Crawley, United Kingdom, RH10 7DX
  • Glasgow, United Kingdom, G46 8NY
  • Hinckley, United Kingdom, LE10 2SE
  • Reading, United Kingdom, RG7 3SQ
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
    • Huntsville, Alabama, United States, 35802
    • Tallassee, Alabama, United States, 36078
  • Arizona
    • Scottsdale, Arizona, United States, 85254
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
  • California
    • Huntington Beach, California, United States, 92646
    • La Jolla, California, United States, 92037
    • Los Angeles, California, United States, 90017
    • Roseville, California, United States, 95661
    • San Francisco, California, United States, 94109
    • Tacoma, California, United States, 98405
  • Colorado
    • Colorado Springs, Colorado, United States, 80904
  • Connecticut
    • New London, Connecticut, United States, 06320
  • District of Columbia
    • Manati, District of Columbia, United States, 00674
  • Florida
    • Daytona Beach, Florida, United States, 32117
    • Hialeah, Florida, United States, 33012
    • Jacksonville, Florida, United States, 32205
    • Miami, Florida, United States, 33186
    • Panama City, Florida, United States, 32401
    • Tampa, Florida, United States, 33606
  • Georgia
    • Augusta, Georgia, United States, 30904
    • Conyers, Georgia, United States, 30094
    • Snellville, Georgia, United States, 30029
  • Hawaii
    • Honolulu, Hawaii, United States, 96813
  • Indiana
    • Indianapolis, Indiana, United States, 46254
    • Indianapolis, Indiana, United States, 46229
    • Lafayette, Indiana, United States, 47905
    • South Bend, Indiana, United States, 46628
  • Maryland
    • Baltimore, Maryland, United States, 21229
  • Massachusetts
    • Brockton, Massachusetts, United States, 02301
  • Michigan
    • Cadillac, Michigan, United States, 49601
  • Minnesota
    • Brooklyn Center, Minnesota, United States, 55430
    • Minneapolis, Minnesota, United States, 55416
  • Missouri
    • St. Peters, Missouri, United States, 63376
  • New York
    • Fulton, New York, United States, 13069
    • Hudson, New York, United States, 12534
    • Rochester, New York, United States, 14609
  • North Carolina
    • Charlotte, North Carolina, United States, 28211
    • Raleigh, North Carolina, United States, 27609
    • Shelby, North Carolina, United States, 28150
    • Statesville, North Carolina, United States, 28625
    • Winston-Salem, North Carolina, United States, 27103
  • Ohio
    • Columbus, Ohio, United States, 43213
    • Delaware, Ohio, United States, 43015
    • Marion, Ohio, United States, 43302
  • Oregon
    • Corvallis, Oregon, United States, 97330
    • Eugene, Oregon, United States, 97401
  • Pennsylvania
    • Aliquippa, Pennsylvania, United States, 15001
    • Beaver, Pennsylvania, United States, 15009
    • Erie, Pennsylvania, United States, 16508
    • Reading, Pennsylvania, United States, 19606
    • Reading, Pennsylvania, United States, 17601
    • Shippensburg, Pennsylvania, United States, 17257
    • Warminster, Pennsylvania, United States, 18974
  • South Carolina
    • Anderson, South Carolina, United States, 29621
  • Tennessee
    • Kingsport, Tennessee, United States, 37660
  • Texas
    • Dallas, Texas, United States, 75230
    • Houston, Texas, United States, 77030
  • Vermont
    • South Burlington, Vermont, United States, 05403
  • Virginia
    • Hampton, Virginia, United States, 23666
    • Norfolk, Virginia, United States, 23502
    • Richmond, Virginia, United States, 23249
    • Richmond, Virginia, United States, 23294
  • 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 of age;
• type 2 diabetes receiving metformin (>=1500mg/day) for at least 12 weeks;
• HbA1c >=7.0% and <=10.0% at screening;
• BMI >=25 (>23 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 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

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Once daily oral administration of placebo (matching sitagliptin). Once weekly sc injection of placebo (matching taspoglutide). Continued treatment with metformin at prescribed doses.	Drug: Metformin; As prescribed; Drug: Placebo (matching sitagliptin); Once daily oral administration of placebo (matching sitagliptin).; Drug: Placebo (matching taspoglutide); Once weekly subcutaneous (sc) injection of placebo (matching taspoglutide).
Active Comparator: Sitagliptin; Once daily oral administration of 100 mg of sitagliptin. Once weekly sc injection of placebo (matching taspoglutide). Continued treatment with metformin at prescribed doses.	Drug: Metformin; As prescribed; Drug: Placebo (matching taspoglutide); Once weekly subcutaneous (sc) injection of placebo (matching taspoglutide).; Drug: Sitagliptin; Once daily oral administration of 100 mg of sitagliptin.
Experimental: Taspoglutide 10 mg; Once weekly subcutaneous (sc) injection of 10 mg of taspoglutide. Once daily oral administration of placebo (matching sitagliptin). Continued treatment with metformin at prescribed doses.	Drug: Metformin; As prescribed; Drug: Placebo (matching sitagliptin); Once daily oral administration of placebo (matching sitagliptin).; Drug: Taspoglutide; Once weekly subcutaneous (sc) injection of 10 mg or 20 mg of taspoglutide.
Experimental: Taspoglutide up-titrated to 20 mg; Once weekly sc injection of 10 mg of taspoglutide for the first 4 weeks, then up-titrated to once weekly sc injection of 20 mg of taspoglutide from week 5 onwards. Once daily oral administration of placebo (matching sitagliptin). Continued treatment with metformin at prescribed doses.	Drug: Metformin; As prescribed; Drug: Placebo (matching sitagliptin); Once daily oral administration of placebo (matching sitagliptin).; Drug: Taspoglutide; Once weekly subcutaneous (sc) injection of 10 mg or 20 mg of taspoglutide.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean changes in HbA1c	24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety: Adverse events, vital signs, physical examination, clinical laboratory tests, ECG and anti-taspoglutide antibodies.	Throughout study
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; change from baseline in lipid profile; beta cell function.	24 weeks

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: September 17, 2008
• First Submitted That Met QC Criteria: September 17, 2008
• First Posted (Estimate): September 18, 2008

Study Record Updates

• Last Update Posted (Estimate): November 4, 2016
• Last Update Submitted That Met QC Criteria: November 3, 2016
• Last Verified: November 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; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Metformin; Sitagliptin Phosphate; Glucagon-Like Peptide 1
• Other Study ID Numbers: BC21713; 2008-001854-42