Safety and Efficacy of Insulin NPH Compared to a New Insulin Formulation in Subjects With Type 2 Diabetes

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Novo Nordisk

Status and phase

Completed
Phase 2

Conditions

Diabetes
Diabetes Mellitus, Type 2

Treatments

Drug: EX1000
Drug: insulin NPH

Study type

Interventional

Funder types

Industry

Identifiers

NCT00660374
EX1000-1865

Details and patient eligibility

About

This trial is conducted in South America. This trial aims for a comparison of the safety and efficacy of insulin NPH and a new insulin formulation on blood glucose control.

Enrollment

402 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Type 2 diabetes for at least 12 months
  • Current NPH treatment for at least 3 months - alone or as the only insulin in combination with OADs
  • Body Mass Index (BMI) less than or equal to 40 kg/m2
  • HbA1c less than or equal to 9.5%
  • FPG less than or equal to 12 mmol/L

Exclusion criteria

  • Treatment with Glucagon-like peptide 1 mimetics or dipeptityl peptidase IV inhibitors
  • Treatment with more than 1 IU/kg NPH insulin daily
  • Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator
  • Known or suspected allergy to trial products or related products
  • Receipt of any investigational drug within one month prior to this trial
  • Any other condition that the Investigator feels would interfere with trial participation or evaluation of results, e.g. shiftworkers

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

402 participants in 2 patient groups

A
Active Comparator group
Treatment:
Drug: insulin NPH
B
Experimental group
Treatment:
Drug: EX1000

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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