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Basal Bolus of Insulin Aspart Including Insulin NPH and Biphasic Insulin Aspart in Type 2 Diabetes
Plain-language guide to NCT00600626: phase 3 randomized trial of Insulin Aspart and NPH Insulin (isophane), 394 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00600626
- Phase
- phase 3
- Status
- completed
- Start
- 2004-01
- Completion (planned or actual)
- 2004-07
- Participants
- 394 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes; Diabetes Mellitus, Type 2
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 3) is built around Insulin Aspart and NPH Insulin (isophane).
This trial is conducted in Europe and Asia.
The aim of this trial is to compare basal bolus treatment with insulin aspart and insulin NPH to biphasic insulin aspart treatment on blood glucose control in type 2 diabetes.
The registry classes the interventions as drug.
Who Took Part
The registry lists 394 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: Type 2 diabetes. Currently treated with human insulin or insulin analogues for at least 3 months, with or without combination with OADs. Body mass index (BMI) below 35.0 kg/m2. Able and willing to perform self-monitoring of blood glucose.
The full record lists 5 inclusion and 3 exclusion criteria; among the exclusions: known or suspected allergy to trial product or related products; pregnancy, breast-feeding, the intention to become pregnant or judged not to be using adequate contraceptive measures.
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
Because people in this Insulin Aspart 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.
Nothing was hidden in this open-label Insulin Aspart study: the participants and staff both knew the treatment.
It started in 2004-01 with completion listed for 2004-07.
It ran at 55 sites in Germany (8), United Kingdom (8), Spain (7), Sweden (6), Poland (5) and France (4).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): HbA1c (time frame: after 4 months of treatment).
It also tracked 4 secondary outcomes, for example 8-point blood glucose profile, incidence of hypoglycaemic episodes, safety profiles and changes in body weight and vital signs.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin Aspart and NPH Insulin (isophane) in 394 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Insulin Aspart compound page and the NPH Insulin (isophane) compound page, all human trials.
Our Notes on the Compounds
Insulin Aspart: A rapid-acting mealtime insulin analog; brands include NovoLog, NovoRapid and Fiasp.
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.