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Clinical Trials/ISRCTN51125379
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.

Registry
who.int
Start Date
September 14, 2004
End Date
TBD
Last Updated
8 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
ovo Nordisk Limited (UK)

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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