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Clinical Trials/ISRCTN29335793
ISRCTN29335793
Completed
Not Applicable

Insulin combination therapy in type 2 diabetes

Stichting Julius Research (The Netherlands)0 sites200 target enrollmentJuly 19, 2006
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ConditionsDiabetes mellitus type 2 (DM type II)Nutritional, Metabolic, EndocrineDiabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes mellitus type 2 (DM type II)
Sponsor
Stichting Julius Research (The Netherlands)
Enrollment
200
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 19, 2006
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Stichting Julius Research (The Netherlands)

Eligibility Criteria

Inclusion Criteria

  • •1\. Type 2 diabetes patients, male and female, insulin naive, without good glycaemic control for at least three months despite combination of metformin and sulfonylurea therapy and who are referred for insulin therapy by their general practitioner (GP)
  • •2\. Aged 40\-75 years
  • •3\. Haemoglobin HbA1c (HbA1c) \>\=7\.5%

Exclusion Criteria

  • •1\. Type 1 diabetes
  • •2\. C\-peptide \<0\.50 nmol/l
  • •3\. Liver (aspartate aminotransferase \[AST] or alanine aminotransferase \[ALT] \>2 times upper limit of normal) and/or kidney (creatinine \>135 in male patients, \>110 in female patients) problems
  • •4\. Patients who do not read Dutch well enough to answer questionnaires
  • •5\. Pregnancy or lactation
  • •6\. Amputated leg or arm
  • •7\. Intercurrent disease at the discretion of the investigator
  • •8\. Short life expectancy
  • •9\. Contraindications or intolerancy to metformin, sulfonylurea or insulin glargine

Outcomes

Primary Outcomes

Not specified

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