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NCT Number: NCT01358929

A Study of RO6807952 in Patients With Diabetes Mellitus Type 2

This randomized, placebo-controlled, multiple ascending dose study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO6807952. Patients will receive multiple weekly subcutaneous doses of RO6870952. The anticipated time on study treatment is 8 weeks.

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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–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chula Vista, California, United States

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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 to 70 years of age, inclusive
  • Diagnosis of type 2 diabetes >/=3 months and </=10 years prior to screening
  • Fasting plasma glucose >/=110 mg/dL and </=240 mg/dL
  • Patients on a stable dose of metformin for at least 2 months prior to screening
  • Hemoglobin HbA1c >/=6.5% and </=10.5%
  • Body mass index >/=25 kg/m2 and </=42 kg/m2
  • Systolic blood pressure <155 mmHg and diastolic blood pressure <95 mmHg

Exclusion criteria

  • Patients with type 1 diabetes
  • History of significant renal and hepatic diseases
  • History of metabolic acidosis and diabetic gastroparesis
  • History of pancreatitis
  • History of coagulation disorders or unexplained excessive bleeding
  • History of clinically significant cardiovascular disease or severe symptomatic hypoglycemia within 6 months of screening

Treatment and study plan

Placebo

Drug

Placebo to RO6807952

RO6807952

Drug

Escalating subcutaneous dose

Primary outcomes

  1. Safety: Incidence of adverse events

    Time frame: 8 weeks

Secondary outcomes

  1. Blood concentrations of RO6807952

    Time frame: 8 weeks

  2. Effect of RO6807952 on Hemoglobin HbA1c level

    Time frame: 8 weeks

  3. Effect of RO6807952 on glucose level

    Time frame: 8 weeks

  4. Change in meal tolerance test

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Randomized, Placebo-Controlled, Sequential, Multiple-Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MAR701/RO6807952 in Type 2 Diabetic Patients

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
May 24, 2011
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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