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Comparison of Two Biphasic Insulin Regimens
Plain-language guide to NCT04726657: not phased non-randomized trial of NPH Insulin (isophane), 36 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04726657
- Phase
- not phased
- Status
- completed
- Start
- 2016-01-18
- Completion (planned or actual)
- 2020-02-03
- Participants
- 36 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes Mellitus, Type 2
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (not phased) is built around NPH Insulin (isophane).
Comparison of Two Biphasic Insulin Regimens in Well-controlled Patients With the Use of Continuous Glucose Monitoring and New Glycemic Control Indices.
It had two arms (groups): Premixed Insulin (active comparator) and Premixed insulin (active comparator).
Premixed Human Insulin.
Premixed Insulin Analog.
The registry classes the interventions as drug.
More on the Plan
A cross-over study of 36 well controlled people with type 2 Diabetes Mellitus who underwent 7-day Continuous Glucose Monitoring with Premixed Human Insulin 30/70 and subsequently with Biphasic Aspart 30.
Who Took Part
Enrollment: 36 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: The patients were on Premixed Human Insulin 30/70 twice daily with or without metformin.
The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: the presence of type 1 diabetes mellitus; stage 4 chronic kidney disease; use of antidiabetic medications other than insulin and metformin.
How the Study Was Run
The set-up was non-randomized, crossover and open-label.
In the crossover set-up each of the participants took both NPH Insulin (isophane) and the comparison in turn, acting as their own control.
Nothing was hidden in this open-label NPH Insulin (isophane) study: the participants and staff both knew the treatment.
It started in 2016-01-18 with completion listed for 2020-02-03.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Change in average blood glucose (time frame: 7 days). Glycated Albumin (time frame: 7 days). Fructosamine (time frame: 7 days).
It also tracked 5 secondary outcomes, for example Daily Insulin requirements, nocturnal average blood glucose, Time in range, time above 180 and time below 70.
What This Means in Plain Language
Put simply, this is a not phased, non-randomized trial of NPH Insulin (isophane) in 36 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 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.