Effect of Insulin Detemir on Blood Glucose Control in Subjects With Type 2 Diabetes
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ClinicalTrials.gov Identifier: NCT00383877 |
Recruitment Status
:
Completed
First Posted
: October 4, 2006
Last Update Posted
: November 21, 2014
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetes Diabetes Mellitus, Type 2 | Drug: insulin detemir Drug: insulin NPH | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 263 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Effect of Insulin Detemir on Blood Glucose Control in Subjects With Type 2 Diabetes |
Study Start Date : | September 2006 |
Actual Primary Completion Date : | August 2007 |
Actual Study Completion Date : | August 2007 |

- HbA1c [ Time Frame: after 20 weeks of treatment ]
- FBG [ Time Frame: after 20 weeks of treatment ]
- Safety profile [ Time Frame: during 20 weeks treatment ]
- Proportion of subjects achieving HbA1c less than or equal to 7.0% [ Time Frame: after 20 weeks of treatment ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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): NCT00383877
China | |
Beijing, China |
Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
Additional Information:
Responsible Party: | Novo Nordisk A/S |
ClinicalTrials.gov Identifier: | NCT00383877 History of Changes |
Other Study ID Numbers: |
NN304-1684 |
First Posted: | October 4, 2006 Key Record Dates |
Last Update Posted: | November 21, 2014 |
Last Verified: | November 2014 |
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 |