NCT01774968

Two Treatment Approaches for Human Regular U-500 Insulin (Thrice-Daily Versus Twice-Daily) in Subjects With Type 2 Diabetes Mellitus Not Achieving Adequate Glycemic Control on High-Dose U-100 Insulin Therapy With or Without Oral Agents: A Randomized, Open-Label, Parallel Clinical Trial

Completed Phase 4 Results posted Last updated 3 September 2015

What this trial tests

Phase 4 trial testing Human Regular U-500 Insulin in Diabetes Mellitus, Type 2 in 325 participants. Completed in 1 May 2014.

Timeline

1 February 2013

Primary endpoint
1 May 2014

1 May 2014

Quick facts

Lead sponsor	Eli Lilly and Company
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	325
Start date	1 February 2013
Primary completion	1 May 2014
Estimated completion	1 May 2014
Sites	39 locations across United States, Puerto Rico

Drugs / interventions tested

• Human Regular U-500 Insulin — full drug profile →

Conditions studied

• Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →

Sponsor

Eli Lilly and Company — full company profile →

Who can join

Adults 18 to 75, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change From Baseline to Week 24 in Glycated Hemoglobin A1c (HbA1c)
  Time frame: Baseline, Week 24
  Least Squares (LS) means of change from baseline were calculated using a mixed-effects model for repeated measures (MMRM) with investigator, baseline total daily dose (TDD; ≤300 or \>300 units), treatment (TID or BID), visit, and treatment-by-visit interaction as fixed effects and baseline HbA1c as a covariate.

Sponsor's own description

The main purpose of this study is to compare the effectiveness of Human Regular U-500 Insulin three times a day versus twice a day.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pathophysiology and treatment of type 2 diabetes: perspectives on the past, present, and future.
   Kahn SE, Cooper ME, Del Prato S. · · 2014 · cited 1100× · PMID 24315620 · DOI 10.1016/s0140-6736(13)62154-6
2. Patient-reported outcomes in transition from high-dose U-100 insulin to human regular U-500 insulin in severely insulin-resistant patients with type 2 diabetes: analysis of a randomized clinical trial.
   Kabul S, Hood RC, Duan R, DeLozier AM, et al · · 2016 · cited 17× · PMID 27716283 · DOI 10.1186/s12955-016-0541-4