A Study With RO5095932 in Patients With Type 2 Diabetes on Stable Metformin Therapy.

NCT01017302 | Completed Phase 1

• 1 other identifier: NP22709
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO5095932 in adult patients with type 2 diabetes mellitus. Patients that are on stable metformin therapy are eligible to enter the study. There will be a 5-weeks exenatide run in period and a 5-weeks period when co-administered with the study drug. RO5095932 will be administered subcutaneously as a single dose or as escalating doses. Patients will be randomized to receive either active drug or placebo in weeks 1 to 4. Active drug or placebo will be administered once weekly for 4 weeks. Patients who received active drug in weeks 1 to 4 will receive placebo in week 5. Patients who received a single dose of placebo in weeks 1 to 4, will receive a single dose of active drug in week 5. The anticipated time of study treatment is \<6 months. The target sample size is \<100 patients.

Conditions

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (1)

• Safety and Tolerability of various doses of RO5095932

  Weeks 1-4, 6, 8

Secondary Outcomes (3)

• Safety and Tolerability of a single dose of RO5095932

  Week 5, 6, 8

• Pharmacokinetics: blood concentration

  Weeks 1-4, 6, 8

• Pharmacodynamics: glucose, insulin, C-peptide

  Weeks 1-4, 6, 8

Study Arms (4)

1

EXPERIMENTAL

Drug: RO5095932

2

PLACEBO COMPARATOR

Drug: Placebo

3

EXPERIMENTAL

Drug: RO5095932

4

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Placebo DRUG

Subcutenaous once weekly for 4 weeks

2

RO5095932 DRUG

Escalating subcutaneous doses once weekly over a 4 weeks period

1

Eligibility Criteria

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

You may qualify if:

• Adult patients, 18-65 years of age
• Diabetes mellitus, type 2 for at least 6 months before screening
• On treatment with stable doses of metformin for at least 3 months before screening
• BMI between \>/=25 and \</=39

You may not qualify if:

• Type 1 diabetes
• Pancreatitis
• Treatment with insulin for more than one week within 3 months prior to study start

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2009
• First Posted: November 20, 2009
• Study Start: December 1, 2009
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

US (1)