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OpenTrials
Completed

NCT Number: NCT00653341

Effect of Insulin Glargine in Insulin Naïve Subjects With Type 2 Diabetes on Oral Hypoglycemic Agent(s)

The primary objective of this study is to compare the percentage of subjects who reach the target HbA1c level (< or = 7.0% at endpoint) and do not experience symptomatic nocturnal hypoglycemia during treatment with insulin glargine or NPH human insulin.

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Key information

Conditions

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

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-aventis administrative office, Laval, Canada

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Insulin naïve subjects with type 2 diabetes treated with oral hypoglycemic agents
  • Body mass index between 26 and 40 kg/m2
  • HbA1c between 7.5% and 10.0%
  • Fasting plasma glucose >7.8 mmol/L and fasting C-peptide > or =0.25 nmol/L

Treatment and study plan

insulin glargine

Drug

NPH human insulin

Drug

Primary outcomes

  1. Percentage of subjects reaching target HbA1c = or < 7% at endpoint and not experiencing symptomatic nocturnal hypoglycemia

Secondary outcomes

  1. Safety data (Adverse events, vital signs, laboratory values, etc.)

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

Target Glycemic Control and the Incidence of Symptomatic Nocturnal Hypoglycemia in Insulin Naïve Subjects With Type 2 Diabetes on Oral Hypoglycemic Agent(s) and Treated With Insulin Glargine or NPH Human Insulin.

Important dates

Study start
2000
Primary completion
2001
Study completion
2001
First posted
Apr 4, 2008
Registry last updated
Apr 20, 2009

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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