Single Dose Clamp Study To Compare Concentration/Time Profile And Metabolic Activity Profile Of 2 New Formulations Of Insulin Glargine With Lantus

Phase 1

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Drug: insulin glargine U100 HOE901; Drug: insulin glargine U500 HOE901; Drug: insulin glargine U200 HOE901

• Registration Number: NCT02201199
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

To compare the pharmacokinetic (PK) characteristics of single doses of insulin glargine given as U200 and U500 with those of a single dose (SD) of Lantus® U100 in a euglycemic clamp setting in subjects with type 1 diabetes.

Secondary Objectives:

To compare the metabolic activity characteristics of single doses of insulin glargine given as U200 and U500 with those of a single dose of Lantus® U100 in a euglycemic clamp setting in subjects with type 1 diabetes.

To assess the safety and tolerability of single doses of U200, U500 and Lantus® U100 in subjects with type 1 diabetes.

Detailed Description

Total study duration for each subject is between 3.5 and 12 weeks.

Two overnight stays at the unit in each of 3 treatment periods.

Study Timeline

• Study First Submitted: 2014-07-24
• Study First Submitted QC: 2014-07-24
• Study First Posted: 2014-07-25
• Study Start: 2014-08
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-23
• Last Update Posted: 2014-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
insulin glargine U100	insulin glargine U100 HOE901	1 single dose
insulin glargine U500	insulin glargine U500 HOE901	1 single dose
insulin glargine U200	insulin glargine U200 HOE901	1 single dose

Primary Outcome Measures

Name	Time	Method
Area under the serum insulin glargine (INS) concentration curve over the first 12 hours after dosing	12 hours

Secondary Outcome Measures

Name	Time	Method
INS-Area Under the Curve (AUC) over 24 and 36 hours after dosing (INS AUC 0-24 and INS AUC 0-36)	36 hours
AUC up to the last measurable concentration	36 hours
Time to reach 50% of INS-AUC 0-36	36 hours
Time to reach INS-Cmax (INS-tmax)	36 hours
Area under the body-weight-standardized Glucose Infusion Rate (GIR) over the first 12, 24 and 36 hours after dosing (GIR-AUC0-12, GIR-AUC0-24 and, GIR-AUC0-36)	36 hours
Time to reach 50% of GIR-AUC0-36 (T50%-GIR-AUC0-36)	36 hours
Maximum smoothed body weight standardized glucose infusion rate (GIRmax) and time to GIRmax (GIR-Tmax)	36 hours
Duration of blood glucose control (time to elevation of smoothed blood glucose profile above different pre-specific blood glucose levels)	4 days
Safety and tolerability (Number of patients with adverse events, clinically significant changes in vital signs, laboratory parameters)	4 days

Trial Locations

Locations (1)

Investigational Site Number 276001; 🇩🇪 Neuss, Germany