Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus on Basal Plus Mealtime Insulin

NCT ID: NCT01658579

Last Updated: 2015-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2013-05-31

Brief Summary

Primary Objective:

• To compare the glucose control during treatment with a new formulation of insulin glargine and Lantus in adult participants with type 1 diabetes mellitus

Secondary Objectives:

• To compare a new formulation of insulin glargine and Lantus given in the morning or in the evening
• To compare the incidence and frequency of hypoglycemic episodes
• To assess the safety and tolerability of the new formulation of insulin glargine

Detailed Description

• Up to 4-week screening period;
• 16-week open-label comparative efficacy and safety treatment period;
• 4-week post-treatment safety follow-up period.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HOE901-U300 Morning Then Evening

HOE901-U300 (new insulin glargine 300 units per milliliter \[U/mL\]) subcutaneous (SC) injection once daily in morning for 8 weeks during treatment period A, followed by once daily in evening for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 millimole per liter (mmol/L).

Group Type: EXPERIMENTAL

HOE901-U300 (new formulation of insulin glargine)

Intervention Type: DRUG

HOE901-U300 Evening Then Morning

HOE901-U300 (new insulin glargine 300 U/mL) SC injection once daily in evening for 8 weeks during treatment period A, followed by once daily in morning for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 mmol/L.

Group Type: EXPERIMENTAL

HOE901-U300 (new formulation of insulin glargine)

Intervention Type: DRUG

Lantus Morning Then Evening

Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily in morning for 8 weeks during treatment period A, followed by once daily in evening for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 mmol/L.

Group Type: ACTIVE_COMPARATOR

Lantus (insulin glargine)

Intervention Type: DRUG

Lantus Evening Then Morning

Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily in evening for 8 weeks during treatment period A, followed by once daily in morning for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 mmol/L.

Group Type: ACTIVE_COMPARATOR

Lantus (insulin glargine)

Intervention Type: DRUG

Interventions

HOE901-U300 (new formulation of insulin glargine)

Intervention Type: DRUG

Lantus (insulin glargine)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participants with Type 1 diabetes mellitus

Exclusion Criteria

• HbA1c greater than (>) 9% (at screening)
• Participants receiving >0.5 U/kg body weight basal insulin in the last 30 days prior to screening visit
• Participants not on stable insulin dose (+/- 20% total basal insulin dose) in the last 30 days prior to screening visit
• Less than 1 year on any basal plus mealtime insulin
• Participants using pre-mix insulins, human regular insulin as mealtime insulin and/or any antidiabetic drugs other than basal insulin and mealtime analogue insulin in the last 3 months before screening visit
• Use of an insulin pump in the last 6 months before screening visit;
• Any contraindication to use of insulin glargine as defined in the national product label
• Not willing to inject insulin glargine as assigned by the randomization process once daily in the morning or evening
• Hospitalization for diabetic ketoacidosis or history of severe hypoglycemia (requiring 3rd party assistance) in the last 6 months prior to randomization
• Initiation of any glucose-lowering agents in the last 3 months before screening visit
• Weight change of greater than equal to (>=) 5 kg during the last 3 months prior to screening visit
• Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require laser, surgical treatment or injectable drugs during the study period

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Investigational Site Number 840002

Temecula, California, United States

Investigational Site Number 840001

Minneapolis, Minnesota, United States

Investigational Site Number 840003

Portland, Oregon, United States

Countries

United States

References

Bergenstal RM, Bailey TS, Rodbard D, Ziemen M, Guo H, Muehlen-Bartmer I, Ahmann AJ. Comparison of Insulin Glargine 300 Units/mL and 100 Units/mL in Adults With Type 1 Diabetes: Continuous Glucose Monitoring Profiles and Variability Using Morning or Evening Injections. Diabetes Care. 2017 Apr;40(4):554-560. doi: 10.2337/dc16-0684. Epub 2017 Jan 23.

Reference Type: DERIVED

PMID: 28115474 (View on PubMed)

Other Identifiers

U1111-1130-3593

Identifier Type: OTHER

Identifier Source: secondary_id

PDY12777

Identifier Type: -

Identifier Source: org_study_id