DiabetesPhase 2NCT01511172
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
A Phase 2 study testing liraglutide, metformin and glimepiride in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 41 sites in 8 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- liraglutide, metformin and glimepiride
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 145 participants
- Where
- 41 sitesin 8 countries
- Study dates
- Aug 2002to Dec 2002
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
41 sites in 8 countries.
41 sites in 8 countries
United Kingdom14 sites
Novo Nordisk Investigational Site
Addlestone, KT15 2BH
Novo Nordisk Investigational Site
Aylesbury, HP21 7TL
Novo Nordisk Investigational Site
Barnsley, S70 3RJ
Novo Nordisk Investigational Site
Bexhill-on-Sea, TN39 4SP
Novo Nordisk Investigational Site
Caerleon, NP18 1AZ
Novo Nordisk Investigational Site
Camberley, GU15 2NN
Novo Nordisk Investigational Site
Chippenham, SN15 1HP
Novo Nordisk Investigational Site
East Horsley, KT24 6QT
Novo Nordisk Investigational Site
Frome, BA11 1EZ
Novo Nordisk Investigational Site
Magherafelt
Novo Nordisk Investigational Site
Sheffield, S3 9DA
Novo Nordisk Investigational Site
Soham, CB7 5JD
Novo Nordisk Investigational Site
Sunbury-on-Thames, TW16 6RH
Novo Nordisk Investigational Site
Yaxley. Peterborough, PE7 3JL
Germany7 sites
Novo Nordisk Investigational Site
Bad Lauterberg im Harz, 37431
Novo Nordisk Investigational Site
Berlin, 12203
Novo Nordisk Investigational Site
Bochum, 44791
Novo Nordisk Investigational Site
Freiburg im Breisgau, 79106
Novo Nordisk Investigational Site
Kaiserslautern, 67675
Novo Nordisk Investigational Site
Mannheim, 68167
Novo Nordisk Investigational Site
Neuss, 41460
Denmark5 sites
Novo Nordisk Investigational Site
Århus C, 8000
Novo Nordisk Investigational Site
Copenhagen, 2400
Novo Nordisk Investigational Site
Frederiksberg, 2000
Novo Nordisk Investigational Site
Køge, 4600
Novo Nordisk Investigational Site
Thisted, 7700
Australia4 sites
Novo Nordisk Investigational Site
Adelaide, SA 5035
Novo Nordisk Investigational Site
Ashford, 5035
Novo Nordisk Investigational Site
Daw Park, South Australia, 5041
Novo Nordisk Investigational Site
Garran, 2605
France4 sites
Novo Nordisk Investigational Site
La Rochelle, 17019
Novo Nordisk Investigational Site
Narbonne, 11108
Novo Nordisk Investigational Site
Nevers, 58033
Novo Nordisk Investigational Site
Paris, 75475
Austria3 sites
Novo Nordisk Investigational Site
Vienna, 1030
Novo Nordisk Investigational Site
Vienna, A 1090
Novo Nordisk Investigational Site
Vienna, A-1130
Czechia2 sites
Novo Nordisk Investigational Site
České Budějovice, 37001
Novo Nordisk Investigational Site
Prague, 10034
Poland2 sites
Novo Nordisk Investigational Site
Rawa Mazowiecka, 96-200
Novo Nordisk Investigational Site
Zabrze, 41-800
About this study
Official title: 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
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).
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- liraglutide, metformin, placebo, glimepiride
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liraglutideDrug
Individually adjusted dose, maximum 2.0 mg. Injected subcutaneously
metforminDrug
1000 mg daily, administered orally
placeboDrug
Metformin placebo administered orally. 1000 mg daily
placeboDrug
NNC 90-1170 placebo. Individually adjusted dose, maximum 2.0 mg. Injected subcutaneously
glimepirideDrug
Individually adjusted dose, administered orally
| Study group | Role | What they receive |
|---|---|---|
| NNC 90-1170 + Met | Experimental | Not described Receives: Drug: liraglutide; Drug: metformin |
| NNC 90-1170 + Met placebo | Experimental | Not described Receives: Drug: placebo |
| Met + NNC 90-1170 placebo | Placebo comparator | Not described Receives: Drug: metformin; Drug: placebo |
| Met + Glim | Active comparator | Not described Receives: Drug: metformin; Drug: glimepiride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting plasma/serum glucose
Secondary outcomes (10)
Home monitored fasting plasma glucose
Home monitored 7-point glucose profile
Fructosamine
Insulin
C-peptide
HbA1c (glycated haemoglobin A1c)
Weight
Beta-cell function and insulin resistance (HOMA model)
Gastro-intestinal adverse events
Other adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2012 (estimated)
- Study startAug 2002
- Primary completionDec 2002
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01511172
- Sponsor's protocol ID
- NN2211-1499
- Status last verified
- Jan 2017
- First submitted
- 12 Jan 2012
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Nauck MA, Hompesch M, Filipczak R, Le TD, Zdravkovic M, Gumprecht J; NN2211-1499 Study Group. Five weeks of treatment with the GLP-1 analogue liraglutide improves glycaemic control and lowers body weight in subjects with type 2 diabetes. Exp Clin Endocrinol Diabetes. 2006 Sep;114(8):417-23. doi: 10.1055/s-2006-924230.
PubMed 17039422Jensen TM, Saha K, Steinberg WM. 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. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12.
PubMed 25504028
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01511172
- Acronym / sponsor ID
- NN2211-1499
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Aug 2002
- Primary completion
- Dec 2002 (actual)
- Study completion
- Dec 2002 (actual)
- First posted
- 18 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NNC 90-1170 + Met | Experimental | Drug: liraglutide, Drug: metformin |
| NNC 90-1170 + Met placebo | Experimental | Drug: placebo |
| Met + NNC 90-1170 placebo | Placebo comparator | Drug: metformin, Drug: placebo |
| Met + Glim | Active comparator | Drug: metformin, Drug: glimepiride |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liraglutideIndividually adjusted dose, maximum 2.0 mg. Injected subcutaneously | Drug | NNC 90-1170 + Met |
| metformin1000 mg daily, administered orally | Drug | Met + Glim, Met + NNC 90-1170 placebo, NNC 90-1170 + Met |
| placeboMetformin placebo administered orally. 1000 mg daily | Drug | NNC 90-1170 + Met placebo |
| placeboNNC 90-1170 placebo. Individually adjusted dose, maximum 2.0 mg. Injected subcutaneously | Drug | Met + NNC 90-1170 placebo |
| glimepirideIndividually adjusted dose, administered orally | Drug | Met + Glim |
Primary outcome
Fasting plasma/serum glucose
10 secondary outcomes
Home monitored fasting plasma glucose
Home monitored 7-point glucose profile
Fructosamine
Insulin
C-peptide
HbA1c (glycated haemoglobin A1c)
Weight
Beta-cell function and insulin resistance (HOMA model)
Gastro-intestinal adverse events
Other adverse events
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2017.
- Results publication: PubMed 17039422Nauck MA, Hompesch M, Filipczak R, Le TD, Zdravkovic M, Gumprecht J; NN2211-1499 Study Group. Five weeks of treatment with the GLP-1 analogue liraglutide improves glycaemic control and lowers body weight in subjects with type 2 diabetes. Exp Clin Endocrinol Diabetes. 2006 Sep;114(8):417-23. doi: 10.1055/s-2006-924230.
- Results publication: PubMed 25504028Jensen TM, Saha K, Steinberg WM. 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. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
Related trials for Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Registry (GCR, 1452) study director
Novo Nordisk A/S
41 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing liraglutide, metformin and glimepiride in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 41 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United Kingdom, Germany, Denmark, Australia, France and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting plasma/serum glucose. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01511172, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2017.