A Study of DPP-IV Inhibitor in Patients With Type 2 Diabetes

NCT00111631 | Completed Phase 2

• 1 other identifier: BM18106
• Study Type: interventional
• Target: 218
• Locations: 6 countries
• Sites: 37

Brief Summary

This study will assess the efficacy, safety and tolerability of DPP-IV Inhibitor in patients with type 2 diabetes receiving a stable dose of metformin. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.

Conditions

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (1)

• Absolute change from baseline in HbAlc\n

  Week 16

Secondary Outcomes (2)

• Absolute change in FPG and absolute/relative change in insulin sensitivity, beta-cell-function, and lipid profile, response rate\n

  Week 16

• AEs, vital signs, laboratory tests, body weight, waist/hip ratio, ECG\n

  Throughout study

Study Arms (4)

1

EXPERIMENTAL

Drug: DPP-IV Inhibitor; Drug: Metformin

2

EXPERIMENTAL

Drug: DPP-IV Inhibitor; Drug: Metformin

3

EXPERIMENTAL

Drug: DPP-IV Inhibitor; Drug: Metformin

4

PLACEBO COMPARATOR

Drug: Metformin; Drug: Placebo

Interventions

DPP-IV Inhibitor DRUG

Escalating doses po bid

1; 2; 3

Metformin DRUG

As prescribed

1; 2; 3; 4

Placebo DRUG

po bid

4

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;
• stable metformin therapy for \>=3 months before screening.

You may not qualify if:

• women who are pregnant, breast-feeding, or not using an adequate contraceptive method;
• type 1 diabetes;
• any anti-hyperglycemic medication other than metformin in the last 3 months.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (37)

Unknown Facility

Concord, California, 94520, United States

Location

Unknown Facility

Salinas, California, 93901, United States

Location

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San Diego, California, 92161, United States

Location

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Boulder, Colorado, 80304, United States

Location

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Newark, Delaware, 19713, United States

Location

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Wilmington, Delaware, 19085, United States

Location

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Clearwater, Florida, 33765, United States

Location

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Miami, Florida, 33156, United States

Location

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Chicago, Illinois, 60607, United States

Location

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Detroit, Michigan, 48202-2689, United States

Location

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Buffalo, New York, 14209, United States

Location

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Rochester, New York, 14609, United States

Location

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Durham, North Carolina, 27713, United States

Location

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Mogadore, Ohio, 44260, United States

Location

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Portland, Oregon, 97239, United States

Location

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Connellsville, Pennsylvania, 15425, United States

Location

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Warminster, Pennsylvania, 18974, United States

Location

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Dallas, Texas, 75246, United States

Location

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Midland, Texas, 79707, United States

Location

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San Antonio, Texas, 78229, United States

Location

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Adelaide, 5000, Australia

Location

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Sydney, 2050, Australia

Location

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Winnipeg, Manitoba, R3E 3P4, Canada

Location

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Halifax, Nova Scotia, B3H 1V7, Canada

Location

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London, Ontario, NGA 4V2, Canada

Location

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Toronto, Ontario, M5C 2T2, Canada

Location

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Bad Lauterberg im Harz, 37431, Germany

Location

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Berlin, 10115, Germany

Location

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Dresden, 01307, Germany

Location

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Görlitz, 02826, Germany

Location

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Mainz, 55116, Germany

Location

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Neuss, 41460, Germany

Location

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Ancona, 60131, Italy

Location

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Florence, 50100, Italy

Location

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Napoli, 80100, Italy

Location

Unknown Facility

Udine, 33100, Italy

Location

Unknown Facility

Ponce, 00716, Puerto Rico

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Dipeptidyl-Peptidase IV Inhibitors; Metformin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2005
• First Posted: May 25, 2005
• Study Start: May 1, 2005
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2006
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

AU (2); CA (4); IT (4); PR (1); US (20); DE (6)