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Comparison Between GLP 1 Analogues and DPP 4 Inhibitors in Type 1 Diabetes Mellitus
Plain-language guide to NCT01235819: phase 4 randomized trial of Exenatide and Insulin (regular human), 20 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01235819
- Phase
- phase 4
- Status
- completed
- Start
- 2010-11
- Completion (planned or actual)
- 2011-09
- Participants
- 20 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Type 1 Diabetes
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Exenatide and Insulin (regular human).
To study the effects of GLP 1 analogues and DPP 4 inhibitors on newly detected type 1 diabetes patients.
It had three arms (groups): Insulin alone (active comparator), Insulin and Exenatide (active comparator) and Insulin and Sitagliptin (active comparator).
Type 1 DM only on Insulin.
Newly detected Type 1 DM on Insulin and exenatide.
Newly detected Type 1 DM using Insulin and Sitagliptin.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 20 actual participants took part.
It was open to people of any sex aged from 12 years up to 30 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: T1DM \<3 months. GAD Antibody+ or Stimulated C peptide\<0.5 ng/ml. Ketosis at onset. Age \< 30 yr.
The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: age \> 30 yr; pancreas disease.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
Because people in this Exenatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Everyone knew when Exenatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
It started in 2010-11 with completion listed for 2011-09.
It ran at 1 site in India.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: change in insulin requirement (time frame: one year).
It also tracked 1 secondary outcome, for example C peptide response.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Exenatide and Insulin (regular human) in 20 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Exenatide compound page and the Insulin (regular human) compound page, all human trials.
Our Notes on the Compounds
Exenatide: A 39-amino-acid GLP-1 receptor agonist first identified in Gila monster venom; sold as Byetta and Bydureon for type 2 diabetes.
Insulin (regular human): The 51-amino-acid pancreatic hormone that lowers blood glucose; this page covers regular (short-acting) insulin studied in human trials.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.