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

Sanofi

Status and phase: Completed; Phase 2

Conditions: Type 1 Diabetes Mellitus

Treatments: Drug: Lantus (insulin glargine); Drug: HOE901-U300 (new formulation of insulin glargine)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01658579

U1111-1130-3593 (Other Identifier)

PDY12777

Details and patient eligibility

About

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

Full 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.

Enrollment: 59 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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59 participants in 4 patient groups

HOE901-U300 Morning Then Evening

Experimental group

Description:

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).

Treatment:

Drug: HOE901-U300 (new formulation of insulin glargine)

HOE901-U300 Evening Then Morning

Experimental group

Description:

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.

Treatment:

Drug: HOE901-U300 (new formulation of insulin glargine)

Lantus Morning Then Evening

Active Comparator group

Description:

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.

Treatment:

Drug: Lantus (insulin glargine)

Lantus Evening Then Morning

Active Comparator group

Description:

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.

Treatment:

Drug: Lantus (insulin glargine)