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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00318461




Registration number
NCT00318461
Ethics application status
Date submitted
25/04/2006
Date registered
26/04/2006
Date last updated
7/03/2017

Titles & IDs
Public title
To Compare the Effect of Liraglutide When Given Together With Metformin With the Effect of Metformin Given Alone and With the Effect of Glimepiride and Metformin Given Together
Scientific title
Liraglutide Effect and Action in Diabetes (LEAD-2): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Metformin Versus Metformin Monotherapy Versus Metformin and Glimepiride Combination Therapy in Subjects With Type 2 Diabetes
Secondary ID [1] 0 0
NN2211-1572
Universal Trial Number (UTN)
Trial acronym
LEAD-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 0 0
Diabetes Mellitus, Type 2 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - liraglutide
Treatment: Drugs - metformin
Treatment: Drugs - glimepiride
Treatment: Drugs - placebo
Treatment: Drugs - placebo
Treatment: Drugs - liraglutide
Treatment: Drugs - liraglutide

Experimental: Lira 0.6 + Met - Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day

Experimental: Lira 1.2 + Met - Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day

Experimental: Lira 1.8 + Met - Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day

Active comparator: Met Mono - Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo

Active comparator: Met + Glim - Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo


Treatment: Drugs: liraglutide
0.6 mg for s.c. (under the skin) injection.

Treatment: Drugs: metformin
1.5-2.0 g tablets

Treatment: Drugs: glimepiride
4 mg tablets

Treatment: Drugs: placebo
Glimepiride placebo 1 mg and 2 mg tablets

Treatment: Drugs: placebo
Liraglutide placebo 1-3 mL for s.c. (under the skin) injection

Treatment: Drugs: liraglutide
1.2 mg for s.c. (under the skin) injection

Treatment: Drugs: liraglutide
1.8 mg for s.c. (under the skin) injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Glycosylated A1c (HbA1c) at Week 26
Timepoint [1] 0 0
week 0, week 26
Primary outcome [2] 0 0
Change in Glycosylated A1c (HbA1c) at Week 104
Timepoint [2] 0 0
week 0, week 104
Secondary outcome [1] 0 0
Change in Body Weight at Week 26
Timepoint [1] 0 0
week 0, week 26
Secondary outcome [2] 0 0
Change in Body Weight at Week 104
Timepoint [2] 0 0
week 0, week 104
Secondary outcome [3] 0 0
Change in Fasting Plasma Glucose (FPG) at Week 26
Timepoint [3] 0 0
week 0, week 26
Secondary outcome [4] 0 0
Change in Fasting Plasma Glucose (FPG) at Week 104
Timepoint [4] 0 0
week 0, week 104
Secondary outcome [5] 0 0
Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 26
Timepoint [5] 0 0
week 0, week 26
Secondary outcome [6] 0 0
Change in Mean Prandial Increments of Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 104
Timepoint [6] 0 0
week 0, week 104
Secondary outcome [7] 0 0
Change in Mean Post Prandial Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 26
Timepoint [7] 0 0
week 0, week 26
Secondary outcome [8] 0 0
Change in Mean Post Prandial Plasma Glucose Based on Self-measured 7-point Plasma Glucose Profiles at Week 104
Timepoint [8] 0 0
week 0, week 104
Secondary outcome [9] 0 0
Change in Beta-cell Function at Week 26
Timepoint [9] 0 0
week 0, week 26
Secondary outcome [10] 0 0
Change in Beta-cell Function at Week 104
Timepoint [10] 0 0
week 0, week 104
Secondary outcome [11] 0 0
Hypoglycaemic Episodes at Week 26
Timepoint [11] 0 0
weeks 0-26
Secondary outcome [12] 0 0
Hypoglycaemic Episodes at Week 104
Timepoint [12] 0 0
weeks 0-104

Eligibility
Key inclusion criteria
* Subjects diagnosed with type 2 diabetes and treated with oral anti-diabetic drugs (OADs) for at least 3 months
* HbA1c: 7.0-11.0 % (both incl.) in subjects on OAD monotherapy. 7.0-10.0 % (both incl.) in subjects on OAD combination therapy
* Body Mass Index (BMI) less than or equal 40 kg/m2
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Subjects treated with insulin within the last three months
* Subjects with any serious medical condition
* Females of child bearing potential who are pregnant, breast-feeding or have the intention of becoming pregnant or not using adequate contraceptive methods
* Subjects using any drug (except for OADs), which in the Investigator's opinion could interfere with the glucose level (e.g. systemic corticosteroids)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2008
Sample size
Target
Accrual to date
Final
1091
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Broadmeadow
Recruitment hospital [2] 0 0
Novo Nordisk Investigational Site - Penrith
Recruitment hospital [3] 0 0
Novo Nordisk Investigational Site - St Leonards
Recruitment hospital [4] 0 0
Novo Nordisk Investigational Site - Daw Park
Recruitment hospital [5] 0 0
Novo Nordisk Investigational Site - East Ringwood
Recruitment hospital [6] 0 0
Novo Nordisk Investigational Site - Fremantle
Recruitment hospital [7] 0 0
Novo Nordisk Investigational Site - Adelaide
Recruitment hospital [8] 0 0
Novo Nordisk Investigational Site - Auckland
Recruitment hospital [9] 0 0
Novo Nordisk Investigational Site - Bankstown
Recruitment hospital [10] 0 0
Novo Nordisk Investigational Site - Box Hill
Recruitment hospital [11] 0 0
Novo Nordisk Investigational Site - Cairns
Recruitment hospital [12] 0 0
Novo Nordisk Investigational Site - Camperdown
Recruitment hospital [13] 0 0
Novo Nordisk Investigational Site - Christchurch
Recruitment hospital [14] 0 0
Novo Nordisk Investigational Site - Clayton
Recruitment hospital [15] 0 0
Novo Nordisk Investigational Site - Fitzroy
Recruitment hospital [16] 0 0
Novo Nordisk Investigational Site - Garran
Recruitment hospital [17] 0 0
Novo Nordisk Investigational Site - Hornsby
Recruitment hospital [18] 0 0
Novo Nordisk Investigational Site - Malvern
Recruitment hospital [19] 0 0
Novo Nordisk Investigational Site - Perth
Recruitment hospital [20] 0 0
Novo Nordisk Investigational Site - Westmead
Recruitment hospital [21] 0 0
Novo Nordisk Investigational Site - Woodville
Recruitment postcode(s) [1] 0 0
2292 - Broadmeadow
Recruitment postcode(s) [2] 0 0
2751 - Penrith
Recruitment postcode(s) [3] 0 0
2065 - St Leonards
Recruitment postcode(s) [4] 0 0
5041 - Daw Park
Recruitment postcode(s) [5] 0 0
3135 - East Ringwood
Recruitment postcode(s) [6] 0 0
6160 - Fremantle
Recruitment postcode(s) [7] 0 0
5000 - Adelaide
Recruitment postcode(s) [8] 0 0
SA 5035 - Adelaide
Recruitment postcode(s) [9] 0 0
- Auckland
Recruitment postcode(s) [10] 0 0
2200 - Bankstown
Recruitment postcode(s) [11] 0 0
3128 - Box Hill
Recruitment postcode(s) [12] 0 0
4870 - Cairns
Recruitment postcode(s) [13] 0 0
2050 - Camperdown
Recruitment postcode(s) [14] 0 0
8011 - Christchurch
Recruitment postcode(s) [15] 0 0
3168 - Clayton
Recruitment postcode(s) [16] 0 0
3065 - Fitzroy
Recruitment postcode(s) [17] 0 0
2605 - Garran
Recruitment postcode(s) [18] 0 0
2077 - Hornsby
Recruitment postcode(s) [19] 0 0
3144 - Malvern
Recruitment postcode(s) [20] 0 0
6000 - Perth
Recruitment postcode(s) [21] 0 0
2145 - Westmead
Recruitment postcode(s) [22] 0 0
5011 - Woodville
Recruitment outside Australia
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Dundee
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Oxford
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Plymouth
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Sheffield
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Sunbury on Thames

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This trial is conducted in Europe, Oceania, Africa, Asia and South America. This trial is designed to show the effect of treatment with liraglutide when adding to existing metformin therapy and to compare it with the effects of metformin monotherapy and combination therapy of metformin and glimepiride. Two trial periods: A 6 month (26 weeks) randomised, double-blinded period followed by an 18 months open-label extension, in total 2 years (104 weeks).
Trial website
https://clinicaltrials.gov/study/NCT00318461
Trial related presentations / publications
Nauck M, Frid A, Hermansen K, Shah NS, Tankova T, Mitha IH, Zdravkovic M, During M, Matthews DR; LEAD-2 Study Group. Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin, in type 2 diabetes: the LEAD (liraglutide effect and action in diabetes)-2 study. Diabetes Care. 2009 Jan;32(1):84-90. doi: 10.2337/dc08-1355. Epub 2008 Oct 17.
Sullivan SD, Alfonso-Cristancho R, Conner C, Hammer M, Blonde L. Long-term outcomes in patients with type 2 diabetes receiving glimepiride combined with liraglutide or rosiglitazone. Cardiovasc Diabetol. 2009 Feb 26;8:12. doi: 10.1186/1475-2840-8-12.
Nauck M, Marre M. Adding liraglutide to oral antidiabetic drug monotherapy: efficacy and weight benefits. Postgrad Med. 2009 May;121(3):5-15. doi: 10.3810/pgm.2009.05.1997.
McGill JB. Insights from the Liraglutide Clinical Development Program--the Liraglutide Effect and Action in Diabetes (LEAD) studies. Postgrad Med. 2009 May;121(3):16-25. doi: 10.3810/pgm.2009.05.1998.
Blonde L, Russell-Jones D. The safety and efficacy of liraglutide with or without oral antidiabetic drug therapy in type 2 diabetes: an overview of the LEAD 1-5 studies. Diabetes Obes Metab. 2009 Dec;11 Suppl 3:26-34. doi: 10.1111/j.1463-1326.2009.01075.x.
Jendle J, Nauck MA, Matthews DR, Frid A, Hermansen K, During M, Zdravkovic M, Strauss BJ, Garber AJ; LEAD-2 and LEAD-3 Study Groups. Weight loss with liraglutide, a once-daily human glucagon-like peptide-1 analogue for type 2 diabetes treatment as monotherapy or added to metformin, is primarily as a result of a reduction in fat tissue. Diabetes Obes Metab. 2009 Dec;11(12):1163-72. doi: 10.1111/j.1463-1326.2009.01158.x.
Buse JB, Garber A, Rosenstock J, Schmidt WE, Brett JH, Videbaek N, Holst J, Nauck M. 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. J Clin Endocrinol Metab. 2011 Jun;96(6):1695-702. doi: 10.1210/jc.2010-2822. Epub 2011 Mar 30.
Bode BW, Brett J, Falahati A, Pratley RE. Comparison of the efficacy and tolerability profile of liraglutide, a once-daily human GLP-1 analog, in patients with type 2 diabetes >/=65 and <65 years of age: a pooled analysis from phase III studies. Am J Geriatr Pharmacother. 2011 Dec;9(6):423-33. doi: 10.1016/j.amjopharm.2011.09.007. Epub 2011 Nov 4.
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Public notes

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Novo Nordisk A/S
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Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00318461