A Study Comparing Dulaglutide With Insulin Glargine on Glycemic Control in Participants With Type 2 Diabetes (T2D) and Moderate or Severe Chronic Kidney Disease (CKD)

Plain-language guide to NCT01621178: phase 3 randomized trial of Insulin Glargine and Insulin Lispro, 577 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT01621178
Phase: phase 3
Status: completed
Start: 2012-07
Completion (planned or actual): 2016-06
Participants: 577 (actual)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Type 2 Diabetes; Chronic Kidney Disease
Results posted: yes

What This Study Did, in Plain Language

What Was Tested

The trial (phase 3) is built around Insulin Glargine and Insulin Lispro.

It had three arms (groups): Insulin glargine (active comparator), one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

577 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: Men and non-pregnant women aged ≥18 years. Type 2 diabetes on insulin or insulin + oral antihyperglycemic medication. Able and willing to perform multiple daily injections. Body mass index (BMI) between 23 and 45 kilogram/square meter (kg/m\^2).

The full record lists 6 inclusion and 12 exclusion criteria; among the exclusions: rapidly progressing renal dysfunction likely to require renal replacement; history of a transplanted organ; type 1 diabetes mellitus.

How the Study Was Run

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

Because people in this Insulin Glargine 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.

Being open-label, the Insulin Glargine study did not mask who received what.

It started in 2012-07 with completion listed for 2016-06.

It ran at 89 sites in United States (47), Hungary (8), Brazil (7), Romania (6), Mexico (5) and South Africa (5).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change From Baseline in Hemoglobin A1c (HbA1c) (time frame: Baseline, 26 Weeks).

It also tracked 28 secondary outcomes, for example Change From Baseline in 8-Point Self-Monitored Plasma Glucose (SMPG), Change From Baseline in Fasting Glucose (FG), Change From Baseline in Serum Creatinine (sCr), Change From Baseline in Estimated Glomerular Filtration Rate (eGFR), Change From Baseline in Estimated Creatinine Clearance (eCrCl) and Change From Baseline in Urinary Albumin to Creatinine Ratio (UACR).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Lispro in 577 people.

With 577 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin Glargine compound page and the Insulin Lispro compound page, all human trials.

Our Notes on the Compounds

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

Insulin Lispro: A rapid-acting mealtime insulin analog; brands include Humalog, Admelog and Lyumjev.

Dulaglutide: A once-weekly GLP-1 receptor agonist (two GLP-1 analog chains joined to an antibody Fc fragment), sold as Trulicity.

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.