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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Assessment of Safety and Efficacy of Biphasic Human Insulin IU 100 to EX1000 on Glycaemic Control in Subjects With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00698802
• Other study ID #: EX1000-1919
• Status: Completed
• Phase: Phase 2
• First received: June 16, 2008
• Last updated: April 13, 2015
• Start date: June 2008
• Est. completion date: March 2009

Study information

• Verified date: April 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of HealthSouth Africa: Medicines Control CouncilUnited Arab Emirates: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 397
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• EX1000
Treat-to-target titration scheme, s.c. injection
• biphasic human insulin
Treat-to-target titration scheme, s.c. injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

India,  South Africa,  United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c		after 8 weeks of treatment	No
Secondary	HbA1c		For the duration of the trial	No
Secondary	Fructosamine		For the duration of the trial	No
Secondary	FPG		For the duration of the trial	No
Secondary	4-point SMPG profiles		For the duration of the trial	No
Secondary	Incidence of hypoglycaemic episodes		For the duration of the trial	Yes
Secondary	Frequency and severity of adverse events (including injection site reactions)		For the duration of the trial	Yes
Secondary	Laboratory safety parameters (haematology, biochemistry and lipids)		For the duration of the trial	Yes
Secondary	Physical examination and vital signs		For the duration of the trial	Yes
Secondary	Total daily insulin dosages		For the duration of the trial	No

External Links

•   Clinical Trials at Novo Nordisk