ISRCTN34091554
Completed
Not Applicable
A double-blind, randomised, crossover study to investigate the difference in frequency of episodes of hypoglycaemia during treatment with Biphasic Insulin Aspart 30 (NovoMix®30) compared to Biphasic Human Insulin 30 (Mixtard® 30) in patients with well-controlled, type 2 diabetes
ovo Nordisk Ltd (UK)0 sites160 target enrollmentJune 19, 2006
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 2 diabetes requiring insulin
- Sponsor
- ovo Nordisk Ltd (UK)
- Enrollment
- 160
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. 160 male or female, adult subjects, with type 2 diabetes and treated with 1 \- 3 injections of insulin daily for at least six months
- •2\. HbA1c less than 9\.5% at screening and 6\.5 \- 8\.5 at randomisation
- •3\. Judged by the investigator to be eligible for a twice a day (BID) mixed\-insulin treatment regimen
Exclusion Criteria
- •1\. Impaired hepatic, renal or cardiac function
- •2\. Concomitant oral hypoglycaemic agents
- •3\. History of frequent severe hypoglycaemic episodes requiring external assistance within the last six months
Outcomes
Primary Outcomes
Not specified
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