Effect of Insulin Glargine in Insulin Naïve Subjects With Type 2 Diabetes on Oral Hypoglycemic Agent(s)
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ClinicalTrials.gov Identifier: NCT00653341 |
Recruitment Status :
Completed
First Posted : April 4, 2008
Last Update Posted : April 20, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Mellitus, Type 2 | Drug: insulin glargine Drug: NPH human insulin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 764 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official 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. |
Study Start Date : | January 2000 |
Actual Primary Completion Date : | October 2001 |
Actual Study Completion Date : | October 2001 |

- Percentage of subjects reaching target HbA1c = or < 7% at endpoint and not experiencing symptomatic nocturnal hypoglycemia
- Safety data (Adverse events, vital signs, laboratory values, etc.)

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Ages Eligible for Study: | 30 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00653341
United States, New Jersey | |
Sanofi-aventis administrative office | |
Bridgewater, New Jersey, United States, 08807 | |
Canada | |
Sanofi-aventis administrative office | |
Laval, Canada |
Study Director: | Public Registry ICD | Sanofi |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | ICD Study Director, Sanofi-aventis |
ClinicalTrials.gov Identifier: | NCT00653341 |
Other Study ID Numbers: |
HOE901/4002 |
First Posted: | April 4, 2008 Key Record Dates |
Last Update Posted: | April 20, 2009 |
Last Verified: | April 2009 |
insulin naive |
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Insulin Insulin, Globin Zinc |
Insulin Glargine Isophane Insulin, Human Insulin, Isophane Isophane insulin, beef Hypoglycemic Agents Physiological Effects of Drugs |