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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Effect of Liraglutide or Glimepiride Added to Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes

NCTNCT00614120 (opens ClinicalTrials.gov in a new tab)Other idNN2211-1796
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
929 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Double masking
Countries
3 countries

China, India, South Korea

Start
Jan 2008
Primary completion
Feb 2009
Completion
Feb 2009
First posted
13 Feb 2008 (estimated)
Last update posted
8 Mar 2017
Conditions
Diabetes · Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200820092010
  1. Ph 3

    Effect of Liraglutide or Glimepiride Added to Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes

    NCT00614120

    Jan 2008 to Feb 2009

Registry summary

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

This trial is conducted in Asia. The trial is designed to compare the effect on glycaemic control of liraglutide or glimepiride added to metformin in subjects with type 2 diabetes

Interventions

  • liraglutideDrug
  • placeboDrug
  • liraglutideDrug
  • liraglutideDrug
  • glimepirideDrug
  • metforminDrug
  • placeboDrug

Arms4

  • Experimental

    Lira 0.6 + Met

    Liraglutide 0.6 mg + metformin + glimepiride placebo

  • Experimental

    Lira 1.2 + Met

    Liraglutide 1.2 mg + metformin + glimepiride placebo

  • Experimental

    Lira 1.8 + Met

    Liraglutide + metformin + glimepiride placebo

  • Experimental

    Glim + Met

    Glimepiride 4.0 mg + metformin + liraglutide placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in Glycosylated Haemoglobin A1c (HbA1c)

    Time frame · week 0, week 16

    Registry description

    Percentage point change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 16 weeks (end of treatment).

Secondary outcomes(7)

  1. Change in Body Weight

    Time frame · week 0, week 16

    Registry description

    Change in body weight from baseline (week 0) to 16 weeks (end of treatment)

  2. Change in Self-measured Fasting Plasma Glucose

    Time frame · week 0, week 16

    Registry description

    Change in self-measured fasting plasma glucose from baseline (week 0) to 16 weeks (end of treatment). Self-measurement of plasma glucose was performed using a glucose meter and subjects were instructed to record self-measured plasma glucose values into a diary.

  3. 7-point Self-measured Plasma Glucose Profiles

    Time frame · week 0, 8, 12 and 16

    Registry description

    Summary of 7-Point Profiles of Self-Measured Plasma Glucose by Treatment, Week and Time. The 7 time points for self-measurements for all treatment groups were: Before each meal (breakfast, lunch and dinner), at 90 min after start of each meal (breakfast, lunch and dinner) and at bedtime, measured over 16 weeks of treatment (at week 0, 8, 12 and 16).

  4. Change in Beta-cell Function

    Time frame · week 0, week 16

    Registry description

    Change in beta cell function from baseline (week 0) to 16 weeks (end of treatment). Beta-cell function was derived from fasting plasma glucose (FPG) and fasting insulin concentrations using the homeostasic model assessment (HOMA) method which uses the assumption that normal-weight normal subjects aged under 35 years have a 100% beta-cell function (HOMA-B). Beta-cell function: HOMA-B (%) = 20∙fasting insulin\[uU/mL\] divided by (FPG mmol/L\]-3.5).

  5. Change in Fasting Lipid Profile

    Time frame · week 0, week 16

    Registry description

    Change in fasting lipid profiles from baseline (week 0) to 16 weeks (end of treatment). Fasting lipid profiles is based on: * Total Cholesterol (TC) * Low-density Lipoprotein-cholesterol (LDL-C) * Very Low-density Lipoprotein-cholesterol (VLDL-C) * High-density Lipoprotein-cholesterol (HDL-C) * Triglyceride (TG) * Free Fatty Acid (FFA)

  6. Change in Fasting Lipid Profile, APO-B

    Time frame · week 0, week 16

    Registry description

    Change in fasting lipid profiles based on apolipoprotein B (Apo-B) from baseline (week 0) to 16 weeks (end of treatment).

  7. Hypoglycaemic Episodes

    Time frame · weeks 0-16

    Registry description

    Total number of hypoglycaemic episodes over 16 weeks of treatment occurring from baseline (week 0) to end of treatment (week 16). Hypoglycaemic episodes were defined as major, minor, or symptoms only. Major if the subject was unable to treat her/himself. Minor if subject was able to treat her/himself and plasma glucose was below 3.1 mmol/L. Symptoms only if subject was able to treat her/himself and with no plasma glucose measurement or plasma glucose higher than or equal to 3.1 mmol/L.

Posted results

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

Primary outcome results

Primary outcomeMean· week 0, week 16

Change in Glycosylated Haemoglobin A1c (HbA1c)

GroupValue (percentage point of total HbA1c)Spread
Lira 0.6 + Met-1.01.04
Lira 1.2 + Met-1.31.09
Lira 1.8 + Met-1.41.23
Glim + Met-1.30.98
Secondary and other outcome results(7)
Secondary outcomeMean· week 0, week 16

Change in Body Weight

GroupValue (kg)Spread
Lira 0.6 + Met-1.82.2
Lira 1.2 + Met-2.32.4
Lira 1.8 + Met-2.42.6
Glim + Met0.12.2
Secondary outcomeMean· week 0, week 16

Change in Self-measured Fasting Plasma Glucose

GroupValue (mg/dL)Spread
Lira 0.6 + Met-1.832.66
Lira 1.2 + Met-1.962.35
Lira 1.8 + Met-2.282.94
Glim + Met-2.132.25
Secondary outcomeMean· week 0, 8, 12 and 16

7-point Self-measured Plasma Glucose Profiles

GroupValue (mg/dl)Spread
Lira 0.6 + Met168.243.5
Lira 1.2 + Met167.542.5
Lira 1.8 + Met168.840.4
Glim + Met163.841.2
Secondary outcomeMean· week 0, week 16

Change in Beta-cell Function

GroupValue (percentage point (%point))Spread
Lira 0.6 + Met15.394.6
Lira 1.2 + Met17.830.4
Lira 1.8 + Met21.778.5
Glim + Met21.843.1
Secondary outcomeMean· week 0, week 16

Change in Fasting Lipid Profile

GroupValue (mmol/L)Spread
Lira 0.6 + Met0.060.74
Lira 1.2 + Met-0.010.77
Lira 1.8 + Met-0.030.73
Glim + Met0.020.73
Secondary outcomeMedian· week 0, week 16

Change in Fasting Lipid Profile, APO-B

GroupValue (g/L)Spread
Lira 0.6 + Met0.020.17
Lira 1.2 + Met0.000.18
Lira 1.8 + Met-0.000.16
Glim + Met0.010.17
Secondary outcomeNumber· weeks 0-16

Hypoglycaemic Episodes

GroupValue (episodes)
Lira 0.6 + Met0
Lira 1.2 + Met0
Lira 1.8 + Met0
Glim + Met2

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Lira 0.6 + MetLiraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo–4 / 23167 / 231
Lira 1.2 + MetLiraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo–8 / 23398 / 233
Lira 1.8 + MetLiraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo–4 / 233113 / 233
Glim + MetGlimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo–4 / 23130 / 231

Each cell reads participants affected / participants at risk, as the registry posted them.

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

Studies5

Studies that cite this trial.

Studies with results

4 studies on this page

Indexing hint: Randomized controlled trial · 2015

5 results

Liraglutide pharmacokinetics and dose-exposure response in Asian subjects with Type 2 diabetes from China, India and South Korea.

Ingwersen et al. 2015Diabetes research and clinical practicecited by 12

PMID 25684604DOI 10.1016/j.diabres.2015.01.001PUB-25684604

Full text at the publisher5 results
Publisher pageSee results (5)

Indexing hint: Meta-analysis (pooled) · 2012

3 results

A meta-analysis of serious adverse events reported with exenatide and liraglutide: acute pancreatitis and cancer.

Alves et al. 2012Diabetes research and clinical practicecited by 142

PMID 23010561DOI 10.1016/j.diabres.2012.09.008PUB-23010561

Full text at the publisher3 results
Publisher pageSee results (3)

Indexing hint: Randomized controlled trial · 2011

11 results

Liraglutide provides similar glycaemic control as glimepiride (both in combination with metformin) and reduces body weight and systolic blood pressure in Asian population with type 2 diabetes from China, South Korea and India: a 16-week, randomized, double-blind, active control trial(*).

Yang et al. 2011Diabetes, obesity & metabolismcited by 78

PMID 21114607DOI 10.1111/j.1463-1326.2010.01323.xPUB-21114607

Full text at the publisher11 results
Publisher pageSee results (11)

Indexing hint: Clinical trial · 2011

6 results

Liraglutide treatment is associated with a low frequency and magnitude of antibody formation with no apparent impact on glycemic response or increased frequency of adverse events: results from the Liraglutide Effect and Action in Diabetes (LEAD) trials.

Buse et al. 2011The Journal of clinical endocrinology and metabolismcited by 116

PMID 21450987DOI 10.1210/jc.2010-2822PUB-21450987

Full text at the publisher6 results
Publisher pageSee results (6)

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

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Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Type 2 diabetes * Subjects diagnosed with type 2 diabetes and treated with one or more oral antidiabetic drugs (OADs) for the last 3 months * HbA1c: 7.0-11.0% (both incl.) for subjects on OAD alone * HbA1c: 7.0-10.0 % (both incl.) for subjects on OAD combination therapy * BMI less than 45.0 kg/m\^2 Exclusion Criteria: * Treatment with insulin within the last 3 months prior to the trial * Impaired liver or/and renal function * Significant cardiovascular disease over the last 6 months * Known retinopathy or maculopathy * Recurrent major hypoglycaemia or hypoglycaemic unawareness

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