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

Diabetes Mellitus Type 2 Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO6811135 in Patients With Type 2 Diabetes Mellitus.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01789788
• Other study ID #: BP28436
• Status: Completed
• Phase: Phase 1
• First received: February 8, 2013
• Last updated: November 1, 2016
• Start date: March 2013
• Est. completion date: September 2013

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Placebo
Matching placebo, multiple doses
• RO6811135
multiple ascending doses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Incidence of adverse events		approximately 5 months	No
Secondary	Pharmacokinetics: Area under the concentration-time curve (AUC)		Day 1 and Day 14	No
Secondary	Pharmacodynamics of RO681135: Blood analysis		14 days	No