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Sitagliptin (DPP-4 Inhibitor) and NPH Insulin in Patients With T2D
Plain-language guide to NCT02607410: phase 4 randomized trial of NPH Insulin (isophane), 40 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02607410
- Phase
- phase 4
- Status
- completed
- Start
- 2010-01
- Completion (planned or actual)
- 2012-01
- Participants
- 40 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Type 2 Diabetes Mellitus
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around NPH Insulin (isophane).
To compare the short and long term effects of inhibitor of the DPP-IV enzyme, sitagliptin , with bedtime NPH insulin in patients with T2D inadequately controlled with sulphonylurea plus biguanide: effects on beta cell function and on metabolic profile.
It had two arms (groups): sitagliptin (active comparator) and NPH insulin (active comparator).
The registry classes the interventions as drug.
More on the Plan
Effects on beta cell function and on metabolic profile were analyzed.
Measurements of HbA1c, metabolic and hormonal profile at fasting and post-meal (every 30 minutes for 4 hours) will be evaluated before and after 6 months (short term) and 12 months (long term) of adding sitagliptin or NPH insulin.
Who Took Part
Enrollment: 40 actual participants took part.
It was open to people of any sex aged from 35 years up to 70 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Outpatients with T2D inadequately controlled with metformin plus glyburide. Body mass index \< 35 kg/m2.
The full record lists 3 inclusion and 12 exclusion criteria; among the exclusions: heart failure; respiratory failure; uncontrolled hypertension.
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
Because people in this NPH Insulin (isophane) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
The NPH Insulin (isophane) group and the comparison group ran side by side rather than switching.
Being open-label, the NPH Insulin (isophane) study did not mask who received what.
It started in 2010-01 with completion listed for 2012-01.
It ran at 1 site in Brazil.
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of NPH Insulin (isophane) in 40 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the NPH Insulin (isophane) compound page, all human trials.
Our Notes on the Compound
NPH Insulin (isophane): An intermediate-acting insulin made by combining insulin with protamine; also called isophane or NPH insulin (Humulin N, Novolin N).
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.