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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00660374
• Other study ID #: EX1000-1865
• Status: Completed
• Phase: Phase 2
• First received: February 28, 2008
• Last updated: May 4, 2015
• Start date: February 2008
• Est. completion date: March 2009

Study information

• Verified date: May 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 402
• 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 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

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:
• insulin NPH
"Soft-treat-to-target" dose titration scheme, injection s.c.
• EX1000
"Soft-treat-to-target" dose titration scheme, injection s.c.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	HbA1c		For the duration of the trial	No

External Links

•   Clinical Trials at Novo Nordisk