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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 2

Locations

Brazil

Study Type

Interventional

Intervention

insulin NPH

EX1000

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

HbA1c

Secondary Outcome Measures

Fructosamine

FPG

4-point SMPG profiles

Incidence of hypoglycaemic episodes

Frequency and severity of adverse events (including injection site reactions)

Laboratory safety parameters (haematology, biochemistry and lipids)

Physical examination and vital signs

HbA1c

Full Information

NCT ID

NCT00660374

First Posted

February 28, 2008

Last Updated

May 4, 2015

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT00660374

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

February 2008 (undefined)

Primary Completion Date

March 2009 (Actual)

Study Completion Date

March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

402 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

insulin NPH

Other Intervention Name(s)

Insulatard® 100 IU/mL

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

EX1000

Intervention Description

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

Primary Outcome Measure Information:

Title

HbA1c

Time Frame

For the duration of the trial

Secondary Outcome Measure Information:

Title

Fructosamine

Time Frame

For the duration of the trial

Title

FPG

Time Frame

For the duration of the trial

Title

4-point SMPG profiles

Time Frame

For the duration of the trial

Title

Incidence of hypoglycaemic episodes

Time Frame

For the duration of the trial

Title

Frequency and severity of adverse events (including injection site reactions)

Time Frame

For the duration of the trial

Title

Laboratory safety parameters (haematology, biochemistry and lipids)

Time Frame

For the duration of the trial

Title

Physical examination and vital signs

Time Frame

For the duration of the trial

Title

HbA1c

Time Frame

For the duration of the trial

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Registry (GCR, 1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

City

Salvador

ZIP/Postal Code

40420-000

Country

Brazil

12. IPD Sharing Statement

Links:

URL

http://novonordisk-trials.com

Description

Clinical Trials at Novo Nordisk

Learn more about this trial

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

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