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Trial · Interventional

CompletedPhase 2Registry data

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

NCTNCT01511172 (opens ClinicalTrials.gov in a new tab)Other idNN2211-1499
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
145 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Double masking
Countries
8 countries

Australia, Austria, Czechia, Denmark, France, Germany, Poland, United Kingdom

Start
Aug 2002
Primary completion
Dec 2002
Completion
Dec 2002
First posted
18 Jan 2012 (estimated)
Last update posted
25 Jan 2017 (estimated)
Conditions
Diabetes · Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20022003
  1. Ph 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

    NCT01511172

    Aug 2002 to Dec 2002

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • liraglutideDrug
  • metforminDrug
  • placeboDrug
  • placeboDrug
  • glimepirideDrug

Arms4

  • Experimental

    NNC 90-1170 + Met

  • Experimental

    NNC 90-1170 + Met placebo

  • Placebo comparator

    Met + NNC 90-1170 placebo

  • Active comparator

    Met + Glim

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Fasting plasma/serum glucose

Secondary outcomes(10)

  1. Home monitored fasting plasma glucose

  2. Home monitored 7-point glucose profile

  3. Fructosamine

  4. Insulin

  5. C-peptide

  6. HbA1c (glycated haemoglobin A1c)

  7. Weight

  8. Beta-cell function and insulin resistance (HOMA model)

  9. Gastro-intestinal adverse events

  10. Other adverse events

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2006

7 results

Five weeks of treatment with the GLP-1 analogue liraglutide improves glycaemic control and lowers body weight in subjects with type 2 diabetes.

Nauck et al. 2006Experimental and clinical endocrinology & diabetes : official journal, German Society of Endocrinology [and] German Diabetes Associationcited by 96

PMID 17039422DOI 10.1055/s-2006-924230PUB-17039422

Full text at the publisher7 results
Publisher pageSee results (7)

More studies

1 study on this page

Indexing hint: Meta-analysis (pooled) · 2015

Corrected

Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials.

Jensen et al. 2015Diabetes carecited by 45

PMID 25504028DOI 10.2337/dc13-1210PUB-25504028

Rights unknown
Source linkRead the notice

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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. Exclusion Criteria: * 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

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