Safety and Efficacy of Biphasic Human Insulin Compared to EX1000 in Type 2 Diabetes

Phase 2

Completed

• Conditions: Diabetes; Diabetes Mellitus, Type 2
• Interventions: Drug: EX1000; Drug: biphasic human insulin

• Registration Number: NCT00698802
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Asia and Africa. This trial aims for a comparison of blood glucose control of biphasic human insulin 100 IU/mL and EX1000.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-16
• Study First Submitted QC: 2008-06-16
• Study First Posted: 2008-06-17
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-13
• Last Update Posted: 2015-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 397

Inclusion Criteria

• Type 2 diabetes for at least 12 months
• Current biphasic human insulin (BHI) for at least 3 months - as monotherapy or as the only insulin in combination with OADs
• Body Mass Index (BMI) less than or equal to 40.0 kg/m2
• HbA1c less than or equal to 9.5%
• FPG (SMPG) less than or equal to 12 mmol/L

Exclusion Criteria

• Treatment with more than 1IU/kg insulin daily
• Treatment with Glucagon-like peptide 1 mimetics or dipeptityl peptidase IV inhibitors
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	EX1000	-
B	biphasic human insulin	-

Primary Outcome Measures

Name	Time	Method
HbA1c	after 8 weeks of treatment

Secondary Outcome Measures

Name	Time	Method
Fructosamine	For the duration of the trial
FPG	For the duration of the trial
4-point SMPG profiles	For the duration of the trial
Incidence of hypoglycaemic episodes	For the duration of the trial
Frequency and severity of adverse events (including injection site reactions)	For the duration of the trial
Laboratory safety parameters (haematology, biochemistry and lipids)	For the duration of the trial
Physical examination and vital signs	For the duration of the trial
Total daily insulin dosages	For the duration of the trial
HbA1c	For the duration of the trial