A Study to Compare Taspoglutide and Insulin Glargine in Insulin-Naïve Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin and Sulfonylurea Combination Therapy

NCT01051011 | Terminated Phase 3

• 1 other identifier: ZC22565
• Study Type: interventional
• Target: 370
• Locations: 7 countries
• Sites: 56

Brief Summary

This randomized, open-label, parallel arm study will compare the safety, tolerability and effect on glycemic control of taspoglutide versus insulin glargine in insulin-naïve patients with type 2 diabetes mellitus inadequately controlled on merformin and sulfonylurea combination therapy. Patients will be randomized to receive either taspoglutide 10mg subcutaneously (sc) weekly, or taspoglutide 10mg sc weekly for 4 weeks followed by 20mg sc weekly, or insulin glargine at an initial dose of 10 international units sc daily. Metformin treatment will be continued in all patients throughout the study, whereas sulfonylurea will be discontinued before starting study treatment. Anticipated time on study treatment is 24 weeks, with an option to continue the assigned treatment for another 28 weeks. Target sample size is 500-600 patients.

Conditions

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (1)

• Glycemic control assessed by HbA1c

  week 24

Secondary Outcomes (4)

• Fasting plasma glucose, incidence of hypoglycemia, proportion of patients achieving target HbA1c

  week 24

• Body weight, lipid profile (triglycerides, total cholesterol, LDL and HDL cholesterol, LDL/HDL ratio)

  week 24

• Safety and tolerability: Adverse events (including hypoglycemia), vital signs, laboratory parameters

  throughout study, laboratory assessments weeks 12, 24, 32 and 52

• Meal tolerance test (in a subset of patients): Glucose, insulin, C-peptide, glucagon values

  week 24

Study Arms (3)

1

EXPERIMENTAL

Drug: metformin; Drug: taspoglutide

2

EXPERIMENTAL

Drug: metformin; Drug: taspoglutide

3

ACTIVE COMPARATOR

Drug: insulin glargine; Drug: metformin

Interventions

insulin glargine DRUG

initial dose 10 international units (IU) sc daily, titrated according to the mean FPG, 24 (-52) weeks

3

metformin DRUG

as prescribed

1; 2; 3

taspoglutide DRUG

10mg sc weekly, 24 (-52) weeks

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients, 18-75 years of age
• type 2 diabetes mellitus, treated with stable dose of metformin and sulfonylurea for \>/= 12 weeks prior to screening
• HbA1c 7-10% at screening
• body weight stable (+/-5%) for \>/= 12 weeks prior to screening
• fasting C-peptide \>/=1ng/ml
• treatment-naïve for insulin

You may not qualify if:

• diagnosis or history of type 1 diabetes mellitus or secondary forms of diabetes
• acute metabolic diabetic complications or evidence of clinically significant diabetic complications
• clinically symptomatic gastrointestinal disease
• history of chronic pancreatitis or acute idiopathic pancreatitis
• \>3 episodes of severe hypoglycemia within 6 months prior to screening
• miocardial infarcion, unstable angina pectoris, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within 6 months prior to screening
• any treatment with exenatide, exendin analogues, GLP-1 or its analogues

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (56)

Unknown Facility

Beijing, 10029, China

Location

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Beijing, 100730, China

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Beijing, 100853, China

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Beijng, 100700, China

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Chengdu, 610041, China

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Chongqing, 400010, China

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Guangzhou, 510120, China

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Hangzhou, 310003, China

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Hefei, 230022, China

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Nanjing, 210006, China

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Nanjing, 210036, China

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Nanning, 530021, China

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Shanghai, 200080, China

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Shijiazhuang, 050051, China

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Tianjin, 201203, China

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Tianjin (天津), 300052, China

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Hong Kong, Hong Kong

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George Town, 10450, Malaysia

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Johor Bahru, 80200, Malaysia

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Kelantan, 16150, Malaysia

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Kuala Lumpur, 50586, Malaysia

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Kuala Lumpur, 50603, Malaysia

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Kuala Selangor, Malaysia

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Putrajaya, 62250, Malaysia

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Cebu, 6000, Philippines

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Iloilo City, 5000, Philippines

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Manila, 1000, Philippines

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Manila, 1357, Philippines

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Manila, 1503, Philippines

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Pasig, 1605, Philippines

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Busan, 614-735, South Korea

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Daegu, 42472, South Korea

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Daegu, 705-717, South Korea

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Gyeonggi-do, 410-773, South Korea

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Gyeonggi-do, 443-380, South Korea

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Gyeonggi-do, 463-712, South Korea

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Incheon, 405-760, South Korea

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Kangwon-do, 220-701, South Korea

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Kyounggi-do, 420-717, South Korea

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Seoul, 0, South Korea

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Seoul, 110-746, South Korea

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Seoul, 130-702, South Korea

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Seoul, 134-701, South Korea

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Seoul, 135-720, South Korea

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Seoul, 137-701, South Korea

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Seoul, 139-872, South Korea

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Chia-Yi City, 60002, Taiwan

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Taichung, 404, Taiwan

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Tainan, 710, Taiwan

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Taipei, 00112, Taiwan

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Taipei, 220, Taiwan

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Taoyuan, 333, Taiwan

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Bangkok, 10330, Thailand

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Bangkok, 10400, Thailand

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Chiang Mai, 50200, Thailand

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Nakhonratchasima, 30000, Thailand

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine; Metformin; taspoglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2010
• First Posted: January 18, 2010
• Study Start: January 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

TH (4); HK (1); TW (6); MY (7); CN (16); PH (6); KR (16)