Effect of Insulin Detemir on Blood Glucose Control in Subjects With Type 2 Diabetes
This study has been completed.
Sponsor:
Novo Nordisk A/S
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00383877
First received: October 3, 2006
Last updated: November 20, 2014
Last verified: November 2014
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Purpose
This trial is conducted in China. This trial aims for a comparison of the effect on glycemic control in subjects with type 2 diabetes of insulin detemir or NPH-insulin given once daily at bedtime as add-on to oral anti-diabetic drug(s).
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Diabetes Mellitus, Type 2 |
Drug: insulin detemir Drug: insulin NPH |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effect of Insulin Detemir on Blood Glucose Control in Subjects With Type 2 Diabetes |
Resource links provided by NLM:
Further study details as provided by Novo Nordisk A/S:
Primary Outcome Measures:
- HbA1c [ Time Frame: after 20 weeks of treatment ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- FBG [ Time Frame: after 20 weeks of treatment ] [ Designated as safety issue: No ]
- Safety profile [ Time Frame: during 20 weeks treatment ] [ Designated as safety issue: Yes ]
- Proportion of subjects achieving HbA1c less than or equal to 7.0% [ Time Frame: after 20 weeks of treatment ] [ Designated as safety issue: No ]
- Within-subject variation of self measured blood glucose (SMBG) before breakfast during the trial at the end of the trial [ Time Frame: before breakfast during the trial at the end of the trial ] [ Designated as safety issue: No ]
| Enrollment: | 263 |
| Study Start Date: | September 2006 |
| Study Completion Date: | August 2007 |
| Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Type 2 diabetes
- HbA1C greater than 7.5% and less than or equal to 11.0%
- Currently on any oral antidiabetic drug (OAD) more than or equal to 3 months
Exclusion Criteria:
- Previous acute treatment with insulin for more than 7 days.
- Treatment with OAD(s) which does not adhere to the approval labeling.
- Proliferate retinopathy or maculopathy that has required acute treatment within the last year.
- Known hypoglycaemia unawareness or recurrent major hypoglycaemia, that may interfere with study participation as judged by the Investigator.
Contacts and Locations
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For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00383877
Please refer to this study by its ClinicalTrials.gov identifier: NCT00383877
Locations
| China | |
| Beijing, China | |
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
| Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
More Information
Additional Information:
| Responsible Party: | Novo Nordisk A/S |
| ClinicalTrials.gov Identifier: | NCT00383877 History of Changes |
| Other Study ID Numbers: | NN304-1684 |
| Study First Received: | October 3, 2006 |
| Last Updated: | November 20, 2014 |
| Health Authority: | China: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Insulin, Globin Zinc Isophane insulin, beef |
Insulin Insulin Detemir Isophane Insulin, Human Insulin, Isophane Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 23, 2016