Type 1 DiabetesPhase 4NCT01235819
Comparison Between GLP 1 Analogues and DPP 4 Inhibitors in Type 1 Diabetes Mellitus
A Phase 4 study testing Insulin, Sitagliptin and Exenatide in people with Type 1 Diabetes, run by Command Hospital, India at 1 site in India.
Trial summary
To study the effects of GLP 1 analogues and DPP 4 inhibitors on newly detected type 1 diabetes patients. Read more about this study
- Who is it for?
- Ages 12 to 30 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Insulin, Sitagliptin and Exenatide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- Nov 2010to Sep 2011
- Phase
- Phase 4
- 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 12 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- T1DM <3 months
- GAD Antibody+ or Stimulated C peptide<0.5 ng/ml
- Ketosis at onset
- Age < 30 yr
Who cannot join
- Age > 30 yr
- Pancreas disease
- Significant systemic disease
Trial locations and contacts
1 site in 1 country.
About this study
To study the effects of GLP 1 analogues and DPP 4 inhibitors on newly detected type 1 diabetes patients.
Read the detailed description
Inclusion criteria T1DM <3 months GAD Antibody+ Stimulated C peptide<0.5ng/ml Ketosis at onset Age < 30 yr Exclusion criteria Age > 30 yr Pancreatic disease significant systemic complication
- Conditions
- Type 1 Diabetes
- Being tested
- Insulin, Sitagliptin, Exenatide
- Keywords
- type 1 diabetes, exenatide, sitagliptin
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulinDrug
Also called Premixed Insulin
Exenatide Sitagliptin
SitagliptinDrug
Also called DPP 4 inhibitors
Sitagliptin 100 mg per day oral
ExenatideDrug
Also called GLP 1 analogues
Exenatide 10 micrograms daily twice
| Study group | Role | What they receive |
|---|---|---|
| Insulin alone | Active comparator | Type 1 DM only on Insulin Receives: Drug: Insulin |
| Insulin and Exenatide | Active comparator | Newly detected Type 1 DM on Insulin and exenatide Receives: Drug: Exenatide |
| Insulin and Sitagliptin | Active comparator | Newly detected Type 1 DM using Insulin and Sitagliptin Receives: Drug: Sitagliptin |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in insulin requirement
To assess the change in insulin requirement with use of GLP 1 analogues or DPP 4 inhibitors along with insulin in type 1 diabetes
Measured: one year
Secondary outcomes (1)
C peptide response
To assess the endogenous insulin secretion after one year of use of GLp 1 analogue and DPP 4 inhibitors
Measured: at the end of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionSep 2011
- Study completionSep 2011
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 Type 1 DiabetesStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Command Hospital, India
- Sponsor type
- Other government
- Responsible party
- Principal investigator, KVS Hari Kumar, Command Hospital, India
- Investigators
- The Commandant, MD, Study director, Command Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01235819
- Sponsor's protocol ID
- DM/CHCC/03/2010
- Status last verified
- Jul 2016
- First submitted
- 5 Nov 2010
- Last updated
- 27 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Not permitted
Publications
Hari Kumar KV, Shaikh A, Prusty P. Addition of exenatide or sitagliptin to insulin in new onset type 1 diabetes: a randomized, open label study. Diabetes Res Clin Pract. 2013 May;100(2):e55-8. doi: 10.1016/j.diabres.2013.01.020. Epub 2013 Mar 13.
PubMed 23490599
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between GLP 1 Analogues and DPP 4 Inhibitors in Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01235819
- Acronym / sponsor ID
- DM/CHCC/03/2010
- Conditions
- Type 1 Diabetes
- Keywords
- type 1 diabetes, exenatide, sitagliptin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Command Hospital, IndiaOther government
- Study start
- Nov 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 8 Nov 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.
To study the effects of GLP 1 analogues and DPP 4 inhibitors on newly detected type 1 diabetes patients.
Detailed description
Inclusion criteria T1DM <3 months GAD Antibody+ Stimulated C peptide<0.5ng/ml Ketosis at onset Age < 30 yr Exclusion criteria Age > 30 yr Pancreatic disease significant systemic complication
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Insulin alone | Active comparator | Drug: InsulinType 1 DM only on Insulin |
| Insulin and Exenatide | Active comparator | Drug: ExenatideNewly detected Type 1 DM on Insulin and exenatide |
| Insulin and Sitagliptin | Active comparator | Drug: SitagliptinNewly detected Type 1 DM using Insulin and Sitagliptin |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- T1DM <3 months
- GAD Antibody+ or Stimulated C peptide<0.5 ng/ml
- Ketosis at onset
- Age < 30 yr
Key exclusion criteria (3 listed)
- Age > 30 yr
- Pancreas disease
- Significant systemic disease
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 |
|---|---|---|
| InsulinAlso: Premixed InsulinExenatide Sitagliptin | Drug | Insulin alone |
| SitagliptinAlso: DPP 4 inhibitorsSitagliptin 100 mg per day oral | Drug | Insulin and Sitagliptin |
| ExenatideAlso: GLP 1 analoguesExenatide 10 micrograms daily twice | Drug | Insulin and Exenatide |
Primary outcome
change in insulin requirement
Time frame: one year
To assess the change in insulin requirement with use of GLP 1 analogues or DPP 4 inhibitors along with insulin in type 1 diabetes
1 secondary outcome
C peptide response
Time frame: at the end of one year
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 27 Jul 2016.
- Derived from this study: PubMed 23490599Hari Kumar KV, Shaikh A, Prusty P. Addition of exenatide or sitagliptin to insulin in new onset type 1 diabetes: a randomized, open label study. Diabetes Res Clin Pract. 2013 May;100(2):e55-8. doi: 10.1016/j.diabres.2013.01.020. Epub 2013 Mar 13.
- Individual participant dataSharing planned: No. Not permitted
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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.
The Commandant, MD study director
Command Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Insulin, Sitagliptin and Exenatide in people with Type 1 Diabetes, run by Command Hospital, India 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 4 inclusion and 3 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 27 Jul 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
change in insulin requirement (time frame: one year). 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 NCT01235819, 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 27 Jul 2016.