ISRCTN51125379
Completed
Phase 1
Treating To Target in Type 2 diabetes
ovo Nordisk Limited (UK)0 sites700 target enrollmentSeptember 14, 2004
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Type 2 diabetes
- Sponsor
- ovo Nordisk Limited (UK)
- Enrollment
- 700
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Current inclusion criteria as of 06/07/2007:
- •1\. Informed consent
- •2\. People with type 2 diabetes for at least 12 months who are insulin naive
- •3\. On maximally tolerated metformin and sulphonylurea therapy for at least four months
- •4\. Males and females, aged 18 years or more
- •5\. Body mass index of 40\.0 kg/m^2 or less
- •6\. HbA1c in the range 7\.0 to 10\.0% inclusive
- •7\. Able and willing to use insulin injections and perform self\-monitoring of plasma glucose for the entire trial period
- •Previous inclusion criteria:
- •1\. 700 subjects with type 2 diabetes
Exclusion Criteria
- •Current exclusion criteria as of 06/07/2007:
- •1\. Current or previous treatment with thiazolidinediones within the last six months
- •2\. Current or previous treatment with an alpha\-glucosidase inhibitor, repaglinide or nateglinide within the past 30 days
- •3\. Oral Antidiabetic (OAD) treatment with three or more OADs within the last six months
- •4\. Diabetes other than type 2 diabetes mellitus
- •5\. Known sight\-threatening retinopathy as judged by the investigator
- •6\. Plasma creatinine 130 micromoles/l or more
- •7\. Cardiac disease defined as:
- •7\.1\. Unstable angina pectoris within the last six months
- •7\.2\. Myocardial infarction (MI) within last six months
Outcomes
Primary Outcomes
Not specified
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