NCT02205528|CompletedPhase 2

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

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

Novo Nordisk A/S ClinicalTrials.gov

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2 other identifiers

NN9709-4336U1111-1189-5627

Study Type

interventional

Target

108

Locations

1 country

Sites

Timeline

RegisteredJul 2014

StartedAug 2014

CompletionSep 2015

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

108

participants targeted

Target at P50-P75 for phase_2 diabetes

Timeline

Completed

Started Aug 2014

Geographic Reach

1 country

20 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.1 years study duration

First Submitted

Initial submission to the registry

July 30, 2014

Completed

1 day until next milestone

First Posted

Study publicly available on registry

July 31, 2014

Completed

18 days until next milestone

Study Start

First participant enrolled

August 18, 2014

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2015

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2015

Completed

Last Updated

July 21, 2020

Status Verified

July 1, 2020

Enrollment Period

1.1 years

First QC Date

July 30, 2014

Last Update Submit

July 20, 2020

Conditions

Diabetes Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (1)

Change in HbA1c
Day 1; Week 8

Secondary Outcomes (9)

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
+4 more secondary outcomes

Study Arms (3)

Treatment Period: Placebo QD

PLACEBO COMPARATOR

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

Drug: MetforminDrug: Placebo

Treatment Period: NNC0090-2746 QD

EXPERIMENTAL

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

Drug: MetforminDrug: NNC0090-2746

Treatment Period: Liraglutide QD

ACTIVE COMPARATOR

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: LiraglutideDrug: Metformin

Interventions

LiraglutideDRUG

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

Treatment Period: Liraglutide QD

MetforminDRUG

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.

Treatment Period: Liraglutide QDTreatment Period: NNC0090-2746 QDTreatment Period: Placebo QD

PlaceboDRUG

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

Treatment Period: Placebo QD

NNC0090-2746DRUG

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

Treatment Period: NNC0090-2746 QD

Eligibility Criteria

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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
+4 more criteria

Contact the study team to confirm eligibility.