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Completed

NCT Number: NCT00517465

A Multiple Ascending Dose Study of R1511 in Patients With Type 2 Diabetes Mellitus.

This 4 arm study will evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of multiple ascending doses of R1511 compared to placebo in patients with type 2 diabetes mellitus. The starting dose of R1511 will be 100mg po bid for 5 1/2 days; this dose will be escalated in subsequent groups of patients to a potential maximum of 1200mg po bid for 5 1/2 days after a satisfactory assessment of blinded safety, tolerability, pharmacokinetic and pharmacodynamic data of the previous dose. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.

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Key information

Conditions

Diabetes Mellitus Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult patients, 18-65 years of age;
  • type 2 diabetic patients;
  • naive to anti-diabetic therapy, or taken off current anti-diabetic therapy for >=2 weeks before first treatment.

Exclusion criteria

  • type 1 diabetes mellitus;
  • clinically significant cardiovascular disease.

Treatment and study plan

Placebo

Drug

po bid

RG1511

Drug

Starting multiple doses of 100mg po bid escalated in subsequent groups of patients to potential maximum multiple dose of 1200mg po bid.

Primary outcomes

  1. AEs, laboratory parameters, vital signs.

    Time frame: Throughout study

  2. Glucose AUC

    Time frame: Days -1, 1 and 8.

Secondary outcomes

  1. Insulin, C-peptide, glucagon and GLP-1 AUC

    Time frame: Days -1, 1 and 8

  2. 24h glucose

    Time frame: Days -1, 1 and 8

  3. Lipid profiles

    Time frame: Days -1 and 8

  4. Pharmacokinetic parameters

    Time frame: Days 1 and 8

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multiple-ascending-dose Study to Investigate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of R1511 in Type 2 Diabetic (T2D) Patients

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Aug 17, 2007
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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