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

NCT00660374 | Completed Phase 2

• 1 other identifier: EX1000-1865
• Study Type: interventional
• Target: 402
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• HbA1c

  For the duration of the trial

Secondary Outcomes (8)

• 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

Study Arms (2)

A

ACTIVE COMPARATOR

Drug: insulin NPH

B

EXPERIMENTAL

Drug: EX1000

Interventions

insulin NPH DRUG

"Soft-treat-to-target" dose titration scheme, injection s.c.

Also known as: Insulatard® 100 IU/mL

A

EX1000 DRUG

"Soft-treat-to-target" dose titration scheme, injection s.c.

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Unknown Facility

Salvador, 40420-000, Brazil

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

Insulin, Isophane; Isophane Insulin, Human

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Regular, Human; Insulin; Proinsulin

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2008
• First Posted: April 17, 2008
• Study Start: February 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: May 5, 2015

Record last verified: 2015-05

Locations

BR (1)