A Study of Once-Daily NNC0090-2746 in Participants With Type 2 Diabetes Inadequately Controlled With Metformin

Sponsor

Novo Nordisk A/S (Industry)

Overall Status

Completed

CT.gov ID

NCT02205528

Collaborator

(none)

108

Enrollment

Locations

Arms

12.9

Actual Duration (Months)

5.4

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This trial is conducted in the United States of America (USA). The aim of the trial is to investigate the efficacy, safety, and tolerability of once-daily subcutaneous (SC) injections of NNC0090-2746 for 12 weeks, as an adjunct to metformin, in participants with T2D.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Diabetes Mellitus Type 2	Drug: Liraglutide Drug: Metformin Drug: Placebo Drug: NNC0090-2746	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

108 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Phase 2a Study With an Open-Label Active Group to Assess the Efficacy and Safety of Once-Daily NNC0090-2746 in Type 2 Diabetic Patients Inadequately Controlled With Metformin

Actual Study Start Date :

Aug 18, 2014

Actual Primary Completion Date :

Sep 15, 2015

Actual Study Completion Date :

Sep 15, 2015

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Treatment Period: Placebo QD Participants will receive daily SC placebo injections during the 12-week, double-blind treatment period.	Drug: Metformin Metformin hydrochloride immediate- or extended-release oral tablets will be supplied by the participant or investigational site as standard-of-care treatment beginning at least 8 weeks prior to randomization and throughout the 12-week treatment period. Metformin will also be continued during the 4-week follow-up. Dose selection will be based upon manufacturer specifications. Drug: Placebo Matching placebo to NNC0090-2746 will be self-administered daily via SC injection.
Experimental: Treatment Period: NNC0090-2746 QD Participants will receive daily 1.8-mg SC injections of NNC0090-2746 during the 12-week, double-blind treatment period.	Drug: Metformin Metformin hydrochloride immediate- or extended-release oral tablets will be supplied by the participant or investigational site as standard-of-care treatment beginning at least 8 weeks prior to randomization and throughout the 12-week treatment period. Metformin will also be continued during the 4-week follow-up. Dose selection will be based upon manufacturer specifications. Drug: NNC0090-2746 NNC0090-2746 solution will be self-administered in daily doses of 1.8 mg via SC injection.
Active Comparator: Treatment Period: Liraglutide QD Participants will receive open-label liraglutide via SC injection during the 12-week treatment period. The dose scheme will be as follows: 0.6 milligrams (mg) each day during Week 1, followed by 1.2 mg each day during Week 2, and 1.8 mg each day from Weeks 3 to 12.	Drug: Liraglutide Liraglutide will be self-administered daily via SC injection according to manufacturer specifications. Drug: Metformin Metformin hydrochloride immediate- or extended-release oral tablets will be supplied by the participant or investigational site as standard-of-care treatment beginning at least 8 weeks prior to randomization and throughout the 12-week treatment period. Metformin will also be continued during the 4-week follow-up. Dose selection will be based upon manufacturer specifications.

Arm

Intervention/Treatment

Placebo Comparator: Treatment Period: Placebo QD

Participants will receive daily SC placebo injections during the 12-week, double-blind treatment period.

Drug: Metformin

Metformin hydrochloride immediate- or extended-release oral tablets will be supplied by the participant or investigational site as standard-of-care treatment beginning at least 8 weeks prior to randomization and throughout the 12-week treatment period. Metformin will also be continued during the 4-week follow-up. Dose selection will be based upon manufacturer specifications.

Drug: Placebo

Matching placebo to NNC0090-2746 will be self-administered daily via SC injection.

Experimental: Treatment Period: NNC0090-2746 QD

Participants will receive daily 1.8-mg SC injections of NNC0090-2746 during the 12-week, double-blind treatment period.

Drug: Metformin

Drug: NNC0090-2746

NNC0090-2746 solution will be self-administered in daily doses of 1.8 mg via SC injection.

Active Comparator: Treatment Period: Liraglutide QD

Participants will receive open-label liraglutide via SC injection during the 12-week treatment period. The dose scheme will be as follows: 0.6 milligrams (mg) each day during Week 1, followed by 1.2 mg each day during Week 2, and 1.8 mg each day from Weeks 3 to 12.

Drug: Liraglutide

Liraglutide will be self-administered daily via SC injection according to manufacturer specifications.

Drug: Metformin

Outcome Measures

Primary Outcome Measures

Change in HbA1c [Day 1; Week 8]

Secondary Outcome Measures

Change in body weight [Day 1; Week 8; Week 12]
Percent change in body weight [Day 1; Week 8; Week 12]
Change in fasting plasma glucose (FPG) [Day 1; Week 12]
Change in post-prandial plasma glucose level [Day -7; Week 12]
Change in post-prandial insulin level [Day -7; Week 12]
Change in post-prandial C-peptide level [Day -7; Week 12]
Change in beta-cell function [Day 1; Week 12]
According to the Homeostasis Model Assessment (HOMA) score
Incidence of treatment-emergent adverse events [Day 1; Week 18]
Change in percent HbA1c [Day 1; Week 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Participants aged 18 to 70 years, inclusive
Active diagnosis of T2D for greater than or equal to (>/=) 3 months
For females of childbearing potential and males with female partners of childbearing potential, agreement to use highly effective contraceptive measures
Treated with a stable dose of metformin for at least 8 weeks prior to randomization, and expected to remain at the same stable dose throughout study participation
Hemoglobin A1c (HbA1c) >/= 7.2% and less than or equal to (</=) 10.5%
Fasting plasma glucose (FPG) less than (<) 250 milligrams per deciliter (mg/dL)
C-peptide greater than (>) 1.5 nanograms per milliliter (ng/mL)
Body mass index (BMI) >/= 27 kilograms per meter-squared (kg/m^{2) and </= 44 kg/m}2
Stable weight (+/- 5%) within 12 weeks prior to Screening
Willing and able to maintain existing diet and exercise habits throughout the study
Capable of performing SC self-injections on a daily basis during the study

Exclusion Criteria:

Females who are pregnant or lactating
History of type 1 diabetes (T1D), diabetes resulting from pancreatic injury, or secondary forms of diabetes such as Cushing's Syndrome or acromegaly
History of acute metabolic complications such as diabetic ketoacidosis or state of hyperosmolar hyperglycemia
History of clinically significant diabetic complications such as diabetic proliferative retinopathy or severe diabetic neuropathy (requiring treatment with antidepressants or opioids)
History of severe hypoglycemia within 6 months prior to Screening
History of chronic gastrointestinal (GI) conditions that could impede gastric emptying or potentially affect the interpretation of the study data
History of weight loss surgery or weight loss procedure involving the GI tract, such as gastric bypass, gastric stapling, or gastric banding
History of an eating disorder (e.g., bulimia, anorexia)
History of malignancy (except treated basal or squamous cell skin cancer) within 5 years prior to Screening
Personal or family history of medullary thyroid carcinoma
History of multiple endocrine neoplasia syndrome type 2
History of chronic or acute pancreatitis or hemochromatosis
History of significant cardiovascular disease (such as congestive heart failure New York Heart Association Class II to IV, myocardial infarction within the previous 6 months, coronary disease, or uncontrolled hypertension)
History of clinically significant renal or liver disease
History of hypersensitivity or previous intolerance to incretin or glucagon analogues
Elevations in lipase or amylase levels at Screening > 1.5 times the upper limit of normal (ULN) and considered clinically significant by the investigator
Positive human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAG), or hepatitis C antibody test at Screening
Receipt of an investigational drug within 30 days or 5 half-lives, whichever is longer, prior to Screening, or active enrollment in another investigational medication or device study
Any condition, disorder, or abnormal laboratory test findings at screening that, in the judgment of the investigator, would interfere with the participant's ability to comply with all study requirements, or would require the administration of a treatment during the study that could potentially affect the interpretation of the study data, or would place the participant at unacceptable risk by his/her participation in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Chino	California	United States	91710
2	Novo Nordisk Investigational Site	Hawaiian Gardens	California	United States	90716
3	Novo Nordisk Investigational Site	Los Angeles	California	United States	90057
4	Novo Nordisk Investigational Site	Spring Valley	California	United States	91978
5	Novo Nordisk Investigational Site	Hialeah	Florida	United States	33012
6	Novo Nordisk Investigational Site	Port Orange	Florida	United States	32127
7	Novo Nordisk Investigational Site	Sanford	Florida	United States	32771
8	Novo Nordisk Investigational Site	Chicago	Illinois	United States	60607
9	Novo Nordisk Investigational Site	Evanston	Illinois	United States	60201
10	Novo Nordisk Investigational Site	Oxon Hill	Maryland	United States	20745
11	Novo Nordisk Investigational Site	Berlin	New Jersey	United States	08009
12	Novo Nordisk Investigational Site	Albuquerque	New Mexico	United States	87102
13	Novo Nordisk Investigational Site	Greensboro	North Carolina	United States	27408
14	Novo Nordisk Investigational Site	Cincinnati	Ohio	United States	45227
15	Novo Nordisk Investigational Site	Tulsa	Oklahoma	United States	74136
16	Novo Nordisk Investigational Site	Eugene	Oregon	United States	97404
17	Novo Nordisk Investigational Site	Knoxville	Tennessee	United States	37920
18	Novo Nordisk Investigational Site	Corpus Christi	Texas	United States	78404
19	Novo Nordisk Investigational Site	Houston	Texas	United States	77074
20	Novo Nordisk Investigational Site	Manassas	Virginia	United States	20110

Sponsors and Collaborators

Novo Nordisk A/S

Investigators

Study Director: Global Clinical Registry (GCR,1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Novo Nordisk A/S

ClinicalTrials.gov Identifier:

NCT02205528

Other Study ID Numbers:

NN9709-4336
U1111-1189-5627

First Posted:

Jul 31, 2014

Last Update Posted:

Jul 21, 2020

Last Verified:

Jul 1, 2020

Additional relevant MeSH terms:

Diabetes Mellitus

Diabetes Mellitus, Type 2

Metformin

Liraglutide

Study Results

No Results Posted as of Jul 21, 2020