Who is sponsoring NCT02201199?

NCT02201199 is sponsored by Sanofi.

What condition does NCT02201199 study?

NCT02201199 studies Type 1 Diabetes Mellitus.

What drugs are being tested in NCT02201199?

Interventions: insulin glargine U200 HOE901, insulin glargine U500 HOE901, insulin glargine U100 HOE901.

What is the status of NCT02201199?

NCT02201199 is currently COMPLETED.

Last reviewed 2014-12-23 · How we verify

A Single-Center, Randomized, Double-Blind, 3-Treatment, 3-Period, 6-Sequence Cross-Over Study To Compare The Pharmacokinetic And Pharmacodynamic Effects of Single Doses of Insulin Glargine Given As U200 And U500 To Lantus® In A Euglycemic Clamp Setting In Subjects With Type 1 Diabetes

NCT02201199 Phase 1 COMPLETED

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.

Details

Lead sponsor	Sanofi
Phase	Phase 1
Status	COMPLETED
Enrolment	36
Start date	2014-08
Completion	2014-11

Conditions

Type 1 Diabetes Mellitus

Interventions

insulin glargine U200 HOE901
insulin glargine U500 HOE901
insulin glargine U100 HOE901

Primary outcomes

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

Countries

Germany