ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of LY900014 Compared to Insulin Lispro in Participants With Type 2 Diabetes (PRONTO-T2D)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03214380
Recruitment Status : Active, not recruiting
First Posted : July 11, 2017
Last Update Posted : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The purpose of this study is to compare LY900014 to insulin lispro, both in combination with insulin glargine or insulin degludec, in participants with type 2 diabetes (T2D).

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: LY900014 Drug: Insulin Lispro Drug: Insulin Glargine Drug: Insulin Degludec Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 670 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double-Blind Comparison of LY900014 to Insulin Lispro, Both in Combination With Insulin Glargine or Insulin Degludec in Adults With Type 2 Diabetes PRONTO-T2D
Actual Study Start Date : July 14, 2017
Actual Primary Completion Date : August 14, 2018
Estimated Study Completion Date : April 8, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LY900014
LY900014 given subcutaneously (SC) with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily.
Drug: LY900014
Administered SC

Drug: Insulin Glargine
Administered SC

Drug: Insulin Degludec
Administered SC

Active Comparator: Insulin Lispro
Insulin lispro given SC with each meal with either basal insulin glargine given SC once or twice daily or insulin degludec given SC once daily.
Drug: Insulin Lispro
Administered SC

Drug: Insulin Glargine
Administered SC

Drug: Insulin Degludec
Administered SC




Primary Outcome Measures :
  1. Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 26 ]
    Change from baseline in HbA1c


Secondary Outcome Measures :
  1. 1-hour Postprandial Glucose (PPG) Excursion during Mixed-Meal Tolerance Test (MMTT) [ Time Frame: Week 26 ]
    1-hour PPG excursion during MMTT

  2. 2-hour PPG Excursion during MMTT [ Time Frame: Week 26 ]
    2-hour PPG excursion during MMTT

  3. Rate of Severe Hypoglycemia [ Time Frame: Baseline through Week 26 ]
    Rate of severe hypoglycemia

  4. Rate of Documented Symptomatic Hypoglycemia [ Time Frame: Baseline through Week 26 ]
    Rate of documented symptomatic hypoglycemia

  5. Change From Baseline in 1,5-Anhydroglucitol (1,5-AG) [ Time Frame: Baseline, Week 26 ]
    Change From baseline in 1,5-AG

  6. Change from Baseline in 10-Point Self-Monitoring Blood Glucose (SMBG) Values [ Time Frame: Baseline, Week 26 ]
    Change from baseline in 10-point SMBG values

  7. Change from Baseline in Insulin Dose [ Time Frame: Baseline, Week 26 ]
    Change from baseline in insulin dose

  8. Change from Baseline in Insulin Treatment Satisfaction Questionnaire (ITSQ) Regimen Inconvenience Domain Score [ Time Frame: Baseline, Week 26 ]
    Change from baseline in ITSQ regimen inconvenience domain score

  9. Change from Baseline in ITSQ Lifestyle Flexibility Domain Score [ Time Frame: Baseline, Week 26 ]
    Change from baseline in ITSQ lifestyle flexibility domain score

  10. Proportion of Participants with HbA1c <7% [ Time Frame: Week 26 ]
    Proportion of participants with HbA1c <7%



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have been diagnosed (clinically) with T2D, based on the World Health Organization (WHO) classification for at least 1 year prior to screening.
  • Have been treated for at least 90 days prior to screening with:

    • Basal insulin (insulin glargine U-100 [Basaglar/Abasaglar or LANTUS] or U-300, insulin detemir, insulin degludec U-100 or U-200, or neutral protamine Hagedorn [NPH] insulin) in combination with at least 1 prandial injection of bolus insulin (insulin lispro U-100 or U-200, insulin aspart, insulin glulisine, or regular insulin) Or
    • Premixed analog or human insulin regimens with any basal and bolus insulin combination injected at least twice daily
  • Participants may be treated with up to 3 of the following oral antihyperglycemic medications (OAMs) in accordance with local regulations:

    • Metformin
    • Dipeptidyl peptidase-4 (DPP-4) inhibitor
    • Sodium glucose cotransporter 2 (SGLT2) inhibitor
    • Sulfonylurea
    • Meglitinide
    • Alpha-glucoside inhibitor
  • Have an HbA1c value between ≥7.0 and ≤10.0%, according to the central laboratory at the time of screening.
  • Have a body mass index (BMI) of ≤45.0 kilograms per meter squared at screening.

Exclusion Criteria:

  • Have been diagnosed, at any time, with type 1 diabetes (T1D) or Latent Autoimmune Diabetes in Adults.
  • Have hypoglycemia unawareness as judged by the investigator.
  • Have had any episode of severe hypoglycemia within the 6 months prior to screening.
  • Have had 1 or more episodes of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the 6 months prior to screening.
  • Have used thiazolidinediones, Glucagon-Like Peptide 1 (GLP-1) receptor agonist, or pramlintide within 90 days prior to screening.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03214380


  Show 138 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: 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

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03214380     History of Changes
Other Study ID Numbers: 16314
I8B-MC-ITRN ( Other Identifier: Eli Lilly and Company )
2015-005357-12 ( EudraCT Number )
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: September 17, 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.


Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Insulin Glargine
Insulin Lispro
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs