NCT01511172|CompletedPhase 2

Effect of Liraglutide as add-on to Metformin Compared to Either Liraglutide or Metformin Alone, or to a Combination of Metformin and a SU (Sulphonylurea) Agent in Subjects With Type 2 Diabetes

Effect on Glycemic Control of Individual Maximum Effective Dose of NNC 90-1170 as Add on Therapy to Metformin Compared to Monotherapy of NNC 90-1170 or Metformin or a Metformin-SU Combination Therapy in Patients With Type 2 Diabetes. A Double-blind, Double-dummy, Randomised, Parallel-group, Dose Titration Study With an Open Labelled OHA Arm

Novo Nordisk A/S ClinicalTrials.gov

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1 other identifier

NN2211-1499

Study Type

interventional

Target

145

Locations

7 countries

Sites

Timeline

RegisteredJan 2012

StartedAug 2002

CompletionDec 2002

Brief Summary

This trial is conducted in Europe and Oceania. The aim of this trial is to assess the effect on glycemic control of NNC 90-1170 (liraglutide) added to metformin compared to metformin given alone in subjects with type 2 diabetes previously treated with OHAs (oral hypoglycaemic agents).

Trial Health

On Track

Trial Health Score

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

Enrollment

145

participants targeted

Target at P50-P75 for phase_2 diabetes

Timeline

Completed

Started Aug 2002

Shorter than P25 for phase_2 diabetes

Geographic Reach

7 countries

37 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

4 months study duration

Study Start

First participant enrolled

August 1, 2002

Completed

4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2002

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed

9.1 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2012

Completed

6 days until next milestone

First Posted

Study publicly available on registry

January 18, 2012

Completed

Last Updated

January 25, 2017

Status Verified

January 1, 2017

Enrollment Period

4 months

First QC Date

January 12, 2012

Last Update Submit

January 24, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Fasting plasma/serum glucose

Secondary Outcomes (10)

Home monitored fasting plasma glucose
Home monitored 7-point glucose profile
Fructosamine
Insulin
C-peptide
+5 more secondary outcomes

Study Arms (4)

NNC 90-1170 + Met

EXPERIMENTAL

Drug: liraglutideDrug: metformin

NNC 90-1170 + Met placebo

EXPERIMENTAL

Drug: placebo

Met + NNC 90-1170 placebo

PLACEBO COMPARATOR

Drug: metforminDrug: placebo

Met + Glim

ACTIVE COMPARATOR

Drug: metforminDrug: glimepiride

Interventions

liraglutideDRUG

Individually adjusted dose, maximum 2.0 mg. Injected subcutaneously

NNC 90-1170 + Met

metforminDRUG

1000 mg daily, administered orally

Met + GlimMet + NNC 90-1170 placeboNNC 90-1170 + Met

placeboDRUG

Metformin placebo administered orally. 1000 mg daily

NNC 90-1170 + Met placebo

glimepirideDRUG

Individually adjusted dose, administered orally

Met + Glim

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients diagnosed with type 2 diabetes and treated with at least 50 % of maximum dose(s) of OHA(s) for at least three months
Duration of type 2 diabetes diagnosis at least one year
HbA1c 8.0-13.0%, both inclusive
Body Mass Index (BMI) between 25-40 kg/m\^2, both inclusive.

You may not qualify if:

Current treatment with thiazolidinediones or insulin initiated within the last four months prior to trial
Impaired liver function
Impaired renal function
Cardiac problems
Uncontrolled treated/untreated hypertension
Cancer or any clinically significant disease or disorder, except for conditions associated to the type 2 diabetes, which in the Investigator's opinion could interfere with the results of the trial
Recurrent major hypoglycaemia as judged by the Investigator
Known or suspected allergy to trial product or related products
Use of any drug (except for OHAs), which in the Investigator's opinion could interfere with the glucose level
Known or suspected abuse of alcohol or narcotics
Any contraindications to metformin or glimepiride according to the local guidelines

Contact the study team to confirm eligibility.