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

Novo Nordisk

Status and phase: Completed; Phase 2

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: biphasic human insulin; Drug: EX1000

Study type: Interventional

Funder types: Industry

Identifiers

NCT00698802

EX1000-1919

Details and patient eligibility

About

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.

Enrollment: 397 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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397 participants in 2 patient groups

A

Experimental group

Treatment:

Drug: EX1000

B

Active Comparator group

Treatment:

Drug: biphasic human insulin