A Safety, Pharmacokinetics and Pharmacodynamics Study of RO6811135 in Patients With Type 2 Diabetes Mellitus

NCT01789788 | Completed Phase 1

• 1 other identifier: BP28436
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 2

Brief Summary

This randomized, double-blind, placebo-controlled, multiple ascending dose study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO6811135 in patients with type 2 diabetes mellitus. Patients will be randomized to receive either RO6811135 or placebo daily for 2 weeks, with a follow-up examination 2 to 3 weeks after the last dose of study drug.

Conditions

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (1)

• Safety: Incidence of adverse events

  approximately 5 months

Secondary Outcomes (2)

• Pharmacokinetics: Area under the concentration-time curve (AUC)

  Day 1 and Day 14

• Pharmacodynamics of RO681135: Blood analysis

  14 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

RO6811135

EXPERIMENTAL

Drug: RO6811135

Interventions

Placebo DRUG

Matching placebo, multiple doses

Placebo

RO6811135 DRUG

multiple ascending doses

RO6811135

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 to 65 years of age, inclusive
• Type 2 diabetes mellitus according to WHO criteria diagnosed for at least 3 months prior to screening
• On stable dose of metformin for at least 2 months prior to screening
• Fasting plasma glucose during the screening period \</= 240 mg/dL
• Hemoglobin A1c (HbA1c) levels at screening \>/= 6.5% and \</= 10.5%
• Evidence of insulin secretory capacity at screening
• Body mass index (BMI) 27 to 42 kg/m2, inclusive
• Females of child-bearing potential and males with female partners of child-bearing potential must agree to use effective contraception as defined by protocol

You may not qualify if:

• Type 1 diabetes
• Acquired or secondary forms of diabetes such as those resulting from pancreatic surgery/injury, cystic fibrosis related diabetes
• History of acute metabolic complications such as diabetic ketoacidosis or state of hyperosmolar hyperglycemia
• Evidence or history of clinically significant diabetic complications such as clinically severe diabetic peripheral neuropathy, clinically significant nephropathy as judged by the investigator, or pre-proliferative/proliferative diabetic retinopathy as judged by the investigator
• History of severe symptomatic hypoglycemia (requiring assistances of a third party) within 6 months prior to screening
• History or presence of clinically significant concomitant disease or disorder
• Hemoglobin level below the lower limit of reference range at screening
• Pregnant or lactating women
• History of anaphylaxis or severe systemic hypersensitivity or allergic reactions

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (2)

Unknown Facility

Chula Vista, California, 91911, United States

Location

Unknown Facility

Cincinnati, Ohio, 45227, 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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2013
• First Posted: February 12, 2013
• Study Start: March 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

US (2)