NCT03751657 - A Research Study to Compare Insulin 287 Once a Week to Insulin Glargine (100 Units/mL) Once a Day in People With Type 2 Diabetes. | Biotech Hunter

Enrollment

247

Participants

Timeline

Start Date

November 29, 2018

Primary Completion Date

December 16, 2019

Study Completion Date

January 17, 2020

Conditions

Diabetes Mellitus, Type 2

Interventions

DRUG

Insulin icodec

Insulin 287 once weekly subcutaneous (s.c.) injections at the starting dose of 70 units. Dose adjustment was done for the individual patient based on the three pre-breakfast self-measured plasma glucose values measured on two days prior to titration and on the day of the contact. The insulin dose adjustment should aim to reach an SMPG of 3.9-6.0 mmol/L (70-108 mg/dL)

DRUG

Placebo (insulin 287)

Participants will receive once weekly s.c. injections of placebo equivalent to insulin 287.

DRUG

Metformin

Metformin is considered as non investigational medicinal product. Subject will continue metformin at stable pre-trial dose.

DRUG

Dipeptidyl peptidase-4 inhibitors

Dipeptidyl peptidase-4 inhibitors are considered as non investigational medicinal products. Subject will continue dipeptidyl peptidase-4 inhibitor at stable pre-trial dose.

DRUG

Insulin glargine

Insulin glargine (100 U/mL) once daily s.c. injections at the starting dose of 10 units. Dose adjustment will be done for the individual patient based on the three pre-breakfast self-measured plasma glucose values measured on two days prior to titration and on the day of the contact. The insulin dose adjustment should aim to reach an SMPG of 3.9-6.0 mmol/L (70-108 mg/dL).

DRUG

Placebo (insulin glargine)

Participants will receive once daily s.c. injections of placebo equivalent to insulin glargine.

Trial Locations (49)

27401

Novo Nordisk Investigational Site, Slaný

28277

Novo Nordisk Investigational Site, Charlotte

28472

Novo Nordisk Investigational Site, Whiteville

30076

Novo Nordisk Investigational Site, Roswell

37404

Novo Nordisk Investigational Site, Chattanooga

37411

Novo Nordisk Investigational Site, Chattanooga

40503

Novo Nordisk Investigational Site, Lexington

62500

Novo Nordisk Investigational Site, Brno

75230

Novo Nordisk Investigational Site, Dallas

78731

Novo Nordisk Investigational Site, Austin

89128

Novo Nordisk Investigational Site, Las Vegas

91101

Novo Nordisk Investigational Site, Trenčín

93003

Novo Nordisk Investigational Site, Ventura

93534

Novo Nordisk Investigational Site, Lancaster

93601

Novo Nordisk Investigational Site, Šahy

94598

Novo Nordisk Investigational Site, Walnut Creek

98057

Novo Nordisk Investigational Site, Renton

75390-9302

Novo Nordisk Investigational Site, Dallas

B3H 1V7

Novo Nordisk Investigational Site, Halifax

L6S 0C6

Novo Nordisk Investigational Site, Brampton

L4K 4M2

Novo Nordisk Investigational Site, Concord

M9R 4E1

Novo Nordisk Investigational Site, Etobicoke

L8M 1K7

Novo Nordisk Investigational Site, Hamilton

N7T 4X3

Novo Nordisk Investigational Site, Sarnia

G0A 4B0

Novo Nordisk Investigational Site, Saint-Marc-des-Carrieres