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Safety and Efficacy of Insulin Detemir in Combination With OAD in Type 2 Diabetes

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Novo Nordisk

Status and phase

Completed
Phase 3

Conditions

Diabetes
Diabetes Mellitus, Type 2

Treatments

Drug: insulin NPH
Drug: insulin detemir

Study type

Interventional

Funder types

Industry

Identifiers

NCT00604396
NN304-1530

Details and patient eligibility

About

This trial is conducted in Europe.

The aim of this trial is to investigate the safety and efficacy of insulin detemir combined with oral anti-diabetic drugs (OADs) versus insulin NPH combined with oral anti-diabetic drugs (OADs) in Type 2 mellitus not well controlled on current therapy on blood glucose control.

Enrollment

477 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Type 2 diabetes for at least 12 months since diagnosis
  • Insulin naive subjects
  • OAD treatment for at least 4 months alone or combined with no more than two OADs
  • Body mass index (BMI) below 35.0 kg/m2
  • HbA1c between 7.5-10.0%
  • Able and willing to use twice a day injections for the entire trial period

Exclusion criteria

  • Current or previous treatment with thiazolidiones within the last 6 months
  • OAD treatment with three or more OADs within the last 6 months
  • Acute insulin treatment for longer than 7 days in a row within the last 6 months
  • Secondary diabetes
  • Known maturity onset of diabetes of young (MODY)
  • Known or suspected allergy to trial product or related products

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

62

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Data sourced from clinicaltrials.gov

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