Evaluation of the Safety and Efficacy of Insulin Glargine + Glulisine or Insulin Regular + NPH Insulin (Isophane Insulin) Use in Type 2 Diabetes Mellitus Patients With Moderate Renal Failure.

Plain-language guide to NCT01122979: phase 4 randomized trial of Insulin (regular human) and Insulin Glargine, 72 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT01122979
Phase: phase 4
Status: completed
Start: 2010-07
Completion (planned or actual): 2013-10
Participants: 72 (actual)
Design: 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 (phase 4) is built around Insulin (regular human) and Insulin Glargine.

It had two arms (groups): group 1: insulin glargine + insulin glulisine (experimental) and group 2 NPH insulin + regular insulin (active comparator).

Insulin glargine once daily + glulisine at meal times.

The registry classes the interventions as drug.

Who Took Part

The registry lists 72 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: Albuminuria or microalbuminuria diabetic retinopathy.

The full record lists 3 inclusion and 12 exclusion criteria; among the exclusions: hypersensibility to insulin glargine or any other component of the insulin formulation; use of investigational medications during the last 12 months or use of any investigational insulin preparation during the last 4 months; history of diabetic ketoacidosis or positive gad antibodies.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Insulin (regular human) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2010-07 with completion listed for 2013-10.

It ran at 10 sites in Brazil (10).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 5 secondary outcomes, for example Weight variation and Creatinine clearance variation.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) and Insulin Glargine in 72 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page and the Insulin Glargine compound page, all human trials.

Our Notes on the Compounds

Insulin (regular human): The 51-amino-acid pancreatic hormone that lowers blood glucose; this page covers regular (short-acting) insulin studied in human trials.

Insulin Glargine: A long-acting insulin analog given once daily; brands include Lantus, Toujeo, Basaglar and Semglee.

NPH Insulin (isophane): An intermediate-acting insulin made by combining insulin with protamine; also called isophane or NPH insulin (Humulin N, Novolin N).

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.