DiabetesLead-InNCT01212133
A Post Marketing Surveillance (PMS) Study of Liraglutide in Subjects With Type 2 Diabetes Mellitus in India
An observational study of Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in India.
Trial summary
This study is conducted in Asia. The aim of this study is to evaluate the safety and effectiveness of liraglutide in subjects with type 2 diabetes mellitus. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- liraglutide
- Type of treatment
- Injection or infusion
- How many people
- 1,386 participants
- Where
- 1 siteIndia
- Study dates
- Nov 2010to Apr 2012
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects with type 2 diabetes, including newly-diagnosed subjects, who are considered to need treatment with liraglutide are eligible for the study
Who may be able to join
- Subjects with type 2 diabetes, including newly-diagnosed patients / those already receiving other anti-diabetic medications including GLP-1 analogues, who require treatment with liraglutide according to the clinical judgment of their treating physician
- Subjects who are capable of giving study-specific signed informed consent before any collection of information
Who cannot join
- Subjects with type 1 diabetes
- Subjects who are or have previously been on liraglutide
- Subjects who have previously been enrolled in the study
- Subjects who are participating in another clinical trial
- Subjects with a hypersensitivity to liraglutide or to any of the excipients (Disodium phosphate dihydrate, propylene glycol, phenol, water for injections)
- Subjects who are pregnant, breast feeding or have the intention of becoming pregnant within the following 6 months
Trial locations and contacts
1 site in 1 country.
About this study
This study is conducted in Asia. The aim of this study is to evaluate the safety and effectiveness of liraglutide in subjects with type 2 diabetes mellitus.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- liraglutide
- 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
Self-administered subcutaneously (under the skin) once daily at any time, independent of meals, in the abdomen, thigh or upper arm.
| Study group | Role | What they receive |
|---|---|---|
| A | Not described Receives: Drug: liraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of serious adverse drug reactions (SADRs) during the study period
Measured: during 26 weeks of treatment
Secondary outcomes (3)
The number of adverse drug reactions (ADR) during the study period
Measured: during 26 weeks of treatment
The number of serious adverse events (SAE) during the study period
Measured: during 26 weeks of treatment
Frequency of hypoglycaemic episodes
Measured: during 26 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2010 (estimated)
- Study startNov 2010
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,386 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
- NCT01212133
- Sponsor's protocol ID
- NN2211-3865
- Other IDs
- U1111-1114-9324
- Acronym
- Lead-In
- Status last verified
- Dec 2016
- First submitted
- 29 Sep 2010
- Last updated
- 16 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Wangnoo SK, Kumar S, Bhattacharyya A, Tripathi S, Akhtar S, Shetty R, Ghosal S. Liraglutide effect and action in diabetes-In (LEAD-In): A prospective observational study assessing safety and effectiveness of liraglutide in patients with type 2 diabetes mellitus treated under routine clinical practice conditions in India. Indian J Endocrinol Metab. 2016 Nov-Dec;20(6):838-845. doi: 10.4103/2230-8210.189232.
PubMed 27867889
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post Marketing Surveillance (PMS) Study of Liraglutide in Subjects With Type 2 Diabetes Mellitus in India
- ClinicalTrials.gov ID
- NCT01212133
- Acronym / sponsor ID
- Lead-In / NN2211-3865
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,386 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 30 Sep 2010 (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 study is conducted in Asia. The aim of this study is to evaluate the safety and effectiveness of liraglutide in subjects with type 2 diabetes mellitus.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Drug: liraglutide |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects with type 2 diabetes, including newly-diagnosed subjects, who are considered to need treatment with liraglutide are eligible for the study
Key inclusion criteria (2 listed)
- Subjects with type 2 diabetes, including newly-diagnosed patients / those already receiving other anti-diabetic medications including GLP-1 analogues, who require treatment with liraglutide according to the clinical judgment of their treating physician
- Subjects who are capable of giving study-specific signed informed consent before any collection of information
Key exclusion criteria (6 listed)
- Subjects with type 1 diabetes
- Subjects who are or have previously been on liraglutide
- Subjects who have previously been enrolled in the study
- Subjects who are participating in another clinical trial
- Subjects with a hypersensitivity to liraglutide or to any of the excipients (Disodium phosphate dihydrate, propylene glycol, phenol, water for injections)
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 |
|---|---|---|
| liraglutideSelf-administered subcutaneously (under the skin) once daily at any time, independent of meals, in the abdomen, thigh or upper arm. | Drug | A |
Primary outcome
The number of serious adverse drug reactions (SADRs) during the study period
Time frame: during 26 weeks of treatment
3 secondary outcomes
The number of adverse drug reactions (ADR) during the study period
Time frame: during 26 weeks of treatment
The number of serious adverse events (SAE) during the study period
Time frame: during 26 weeks of treatment
Frequency of hypoglycaemic episodes
Time frame: during 26 weeks of treatment
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 16 Dec 2016.
- Results publication: PubMed 27867889Wangnoo SK, Kumar S, Bhattacharyya A, Tripathi S, Akhtar S, Shetty R, Ghosal S. Liraglutide effect and action in diabetes-In (LEAD-In): A prospective observational study assessing safety and effectiveness of liraglutide in patients with type 2 diabetes mellitus treated under routine clinical practice conditions in India. Indian J Endocrinol Metab. 2016 Nov-Dec;20(6):838-845. doi: 10.4103/2230-8210.189232.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in India.
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 2 inclusion and 6 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 16 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
The number of serious adverse drug reactions (SADRs) during the study period (time frame: during 26 weeks of treatment). 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 NCT01212133, which also lists 1 linked publication.
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 16 Dec 2016.