A Study Comparing Insulin Intensification Therapies in Patients With Type 2 Diabetes Mellitus

NCT01175811 | Completed Phase 4 Results

• 2 other identifiers: 13492F3Z-CR-IOQD
• Study Type: interventional
• Target: 402
• Locations: 3 countries
• Sites: 14

Brief Summary

The purpose of the study is to compare the effects on overall glycaemic control of two insulin intensification therapies.

Conditions

Diabetes Mellitus, Type 2

Keywords

Metabolic Diseases; Diabetes Mellitus, Type 2; Glargine; Diabetes Mellitus; Insulin LISPRO; Insulin

Outcome Measures

Primary Outcomes (1)

• Change in Haemoglobin A1c (HbA1c) From Baseline to 24 Week Endpoint

  Least Squares (LS) means are calculated using mixed model repeating measures (MMRM) with the change from baseline in HbA1c at all post baseline measurement as dependent variables, treatment, country, visit and treatment by visit interaction as fixed effects, baseline HbA1c value as a covariate and participant as a random effect.

  Baseline, 24 weeks

Secondary Outcomes (9)

• Change in HbA1c From Baseline to 12 Week Endpoint

  Baseline, 12 weeks

• The Percentage of Participants Who Achieved Haemoglobin A1c (HbA1c) Less Than or Equal to 6.5% and Less Than or Equal to 7% at 12 Weeks and 24 Weeks

  12 weeks, 24 weeks

• The 7-point Self-monitored Blood Glucose (SMBG) Profiles at Baseline, 12 Weeks and 24 Weeks.

  Baseline, 12 weeks, and 24 weeks

• Daily Dose of Insulin: Total, Basal, and Prandial

  24 weeks

• Change in Body Mass Index (BMI) From Baseline to 12 and 24 Weeks

  Baseline, 12 weeks, and 24 weeks

Study Arms (2)

Premixed Insulin

EXPERIMENTAL

Twice daily (before breakfast and lunch) insulin lispro mix 50 (50% insulin lispro, 50% insulin lispro protamine suspension \[LM50\]) and once daily (before dinner) insulin lispro mix 25 (25% insulin lispro, 75% insulin lispro protamine suspension \[LM25\])

Drug: Insulin Lispro Premix

Basal-Bolus

ACTIVE COMPARATOR

Once daily (bedtime) insulin glargine and three pre-meal insulin lispro

Drug: Insulin Glargine; Drug: Insulin Lispro

Interventions

Insulin Lispro Premix DRUG

Participant dependent dose, administered subcutaneously for 24 weeks

Also known as: Humalog Mix25, Humalog Mix50, LY275585

Premixed Insulin

Insulin Glargine DRUG

Participant dependent dose, administered subcutaneously for 24 weeks

Basal-Bolus

Insulin Lispro DRUG

Participant dependent dose, administered subcutaneously for 24 weeks

Also known as: Humalog, LY275585

Basal-Bolus

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Present with type 2 diabetes mellitus
• Have been receiving twice-daily premixed insulin therapy with or without metformin and/or alpha-glucosidase inhibitors, for at least six months prior to study entry
• Have Haemoglobin A1c (HbA1c) \>7.0% and \<12.0%

You may not qualify if:

• Within the last 3 months prior to entry into the study, are taking any non-permitted glucose-lowering agents, or are taking any non-permitted oral antihyperglycaemic medications
• Are pregnant or intend to become pregnant during the course of the study, or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable.
• Are women who are breastfeeding.
• Have an irregular sleep/wake cycle (for example, participants who sleep during the day and work during the night).
• Do not regularly consume three meals per day.
• Have a body mass index \>35 kilogram per square meter (kg/m\^2).
• Have had more than one episode of severe hypoglycaemia within 24 weeks prior to entry into the study.
• Have cardiac disease with a functional status that is Class III or IV
• Have a history of renal or liver disease
• Have used less than or equal to 20 Units per day (U/day) of insulin during the past 90 days for more than 14 days (accumulated).

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (14)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Beijing, 100730, China

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Guangzhou, 510515, China

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Kunming, 650032, China

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Nanjing, 210109, China

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Shanghai, 200080, China

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Xi'an, 710032, China

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Daegu, 705-718, South Korea

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Goyang-si, 410-719, South Korea

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Seoul, 130-702, South Korea

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Yeongdeungpo-gu, 150-950, South Korea

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Changhua, 500, Taiwan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Kuei Shan Hsiang, 33305, Taiwan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Sindian City, 23148, Taiwan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Yong Kung City, 71004, Taiwan

Location

Related Publications (1)

• Jia W, Xiao X, Ji Q, Ahn KJ, Chuang LM, Bao Y, Pang C, Chen L, Gao F, Tu Y, Li P, Yang J. Comparison of thrice-daily premixed insulin (insulin lispro premix) with basal-bolus (insulin glargine once-daily plus thrice-daily prandial insulin lispro) therapy in east Asian patients with type 2 diabetes insufficiently controlled with twice-daily premixed insulin: an open-label, randomised, controlled trial. Lancet Diabetes Endocrinol. 2015 Apr;3(4):254-62. doi: 10.1016/S2213-8587(15)00041-8. Epub 2015 Mar 6.

  PMID: 25754414 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Metabolic Diseases; Diabetes Mellitus; Insulin Resistance

Interventions

insulin lispro, isophane insulin lispro drug combination (25:75); Insulin Lispro; Insulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Long-Acting

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2010
• First Posted: August 5, 2010
• Study Start: February 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: December 18, 2013
• Results First Posted: December 18, 2013

Record last verified: 2013-10

Locations

KR (4); TW (4); CN (6)