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

NCT00111670 | Completed Phase 2

• 1 other identifier: BM18102
• Study Type: interventional
• Target: 291
• Locations: 9 countries
• Sites: 40

Brief Summary

This study will assess the efficacy, safety and tolerability of DPP-IV Inhibitor compared to placebo in patients with type 2 diabetes. The anticipated time on study treatment is \< 3 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\n

  Week 12

Secondary Outcomes (2)

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

  Week 12

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

  Throughout study

Study Arms (5)

1

EXPERIMENTAL

Drug: DPP-IV Inhibitor

2

EXPERIMENTAL

Drug: DPP-IV Inhibitor

3

EXPERIMENTAL

Drug: DPP-IV Inhibitor

4

EXPERIMENTAL

Drug: DPP-IV Inhibitor

5

PLACEBO COMPARATOR

Drug: Placebo

Interventions

DPP-IV Inhibitor DRUG

Escalating doses po bid or qd

1; 2; 3; 4

Placebo DRUG

po bid or qd

5

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 diagnosed \>=1 month before screening;
• no previous treatment, or previous treatment with no more than 2 oral medications.

You may not qualify if:

• type 1 diabetes;
• type 2 diabetes treated with insulin or a PPAR gamma agonist during the 3 months before screening;
• patients who are pregnant, breastfeeding or not using a reliable contraceptive method.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (40)

Unknown Facility

Salinas, California, 93901, United States

Location

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Clearwater, Florida, 33765, United States

Location

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Hialeah, Florida, 33013, United States

Location

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Pembroke Pines, Florida, 33029, United States

Location

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Blue Ridge, Georgia, 30513, United States

Location

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Aurora, Illinois, 60504, United States

Location

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Elkton, Maryland, 21921, United States

Location

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Oxon Hill, Maryland, 20745, United States

Location

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Troy, Michigan, 48098, United States

Location

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Pahrump, Nevada, 89048, United States

Location

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Cincinnati, Ohio, 45224, United States

Location

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Portland, Oregon, 97239, 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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Richmond, Virginia, 23249, United States

Location

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Virginia Beach, Virginia, 23451, United States

Location

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Rousse, 7002, Bulgaria

Location

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Sofia, 1233, Bulgaria

Location

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Sofia, 1606, Bulgaria

Location

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San José, 755-1000, Costa Rica

Location

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Tartu, 50406, Estonia

Location

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Tartu, 51014, Estonia

Location

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Ogre, 5001, Latvia

Location

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Riga, 1002, Latvia

Location

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Klaipėda, 92304, Lithuania

Location

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Vilnius, 08661, Lithuania

Location

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Chihuahua City, 31238, Mexico

Location

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Guadalajara, 44340, Mexico

Location

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Guadalajara, 44650, Mexico

Location

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Mexico City, 06726, Mexico

Location

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Mexico City, 14000, Mexico

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Monterrey, 64460, Mexico

Location

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Pachuca, 42086, Mexico

Location

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Ponce, 00716, Puerto Rico

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Bucharest, 020475, Romania

Location

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Cluj-Napoca, 400006, Romania

Location

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Ploieşti, 100163, Romania

Location

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Târgu Mureş, 540011, Romania

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Dipeptidyl-Peptidase IV Inhibitors

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

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: June 1, 2005
• Primary Completion: July 1, 2006
• Study Completion: July 1, 2006
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

ME (7); BU (3); ES (2); RO (4); CO (1); LA (2); PR (1); LI (2); US (18)