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A Study for Type 2 Diabetic Patients

Primary Purpose

Type 2 Diabetes Mellitus

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

Insulin lispro low mixture

Insulin glargine

Insulin lispro

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

30 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Type 2 diabetes mellitus
Receiving oral antihyperglycemic medications (including metformin) without insulin injection in the last 90 days
Hemoglobin A1c (HbA1c) equal to or greater than 7.0% but less than 11.0%
Willing to receive insulin injection while continuing to take the prestudy oral antihyperglycemic medications
Able to perform self monitoring of blood glucose

Exclusion Criteria:

Are taking any other glucose-lowering agents other than metformin, sulfonylurea or Thiazolidinedione (Pioglitazone)
Have taken acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide in the past 6 weeks, or for a total of 30 days or more, in the last 24 weeks
Have a body mass index greater than 35 kg/m2
History or presence of kidney disease
Have cardiac disease (Class III or IV)

Sites / Locations

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Insulin lispro low mixture

Insulin glargine

Arm Description

Insulin lispro low mixture (1, 2 or 3 daily injections)

Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)

Outcomes

Primary Outcome Measures

Change From Baseline to 48 Week Endpoint in Hemoglobin A1c (HbA1c)

Secondary Outcome Measures

Change in Hemoglobin A1c (HbA1c) Over Time

Percentage of Patients Achieving HbA1c <6.5% and <7% Over Time

7-point Self-monitored Blood Glucose Profiles

Change From Baseline in Postprandial Blood Glucose Over Time

The change in blood glucose was evaluated by the GlycoMark™ test. GlycoMark measures levels of 1,5 anhydroglucitol (1,5 AG) in serum or plasma, allowing for the short- to intermediate-term monitoring of glycemic control in patients with diabetes. When 1,5 AG values decrease, serum glucose levels increase.

Daily Total Insulin Dose (U/Day) at 16, 32, and 48 Weeks

Daily Total Insulin Dose Per Body Weight (U/kg/Day) at 16, 32, and 48 Weeks

Change From Baseline to 48 Week Endpoint in Lipid and Cholesterol Profiles

Safety: Number of Participants With Serious and Non-Serious Adverse Events

Safety was assessed via serious adverse events (SAEs) and AEs, the details of which are listed in the Reported Adverse Event section.

Full Information

NCT ID

NCT00548808

First Posted

October 22, 2007

Last Updated

August 20, 2010

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00548808

Brief Title

A Study for Type 2 Diabetic Patients

Official Title

Comparison of Insulin Lispro Low Mixture With Insulin Glargine When Initiating and Intensifying Insulin Therapy As Required in Patients With Type 2 Diabetes Who Have Inadequate Glycemic Control on Oral Antihyperglycemic Medication

Study Type

Interventional

2. Study Status

Record Verification Date

August 2010

Overall Recruitment Status

Completed

Study Start Date

November 2007 (undefined)

Primary Completion Date

August 2009 (Actual)

Study Completion Date

August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of the study is to compare the insulin lispro low mixture (1, 2 or 3 daily injections) with insulin glargine (alone or with 1, 2 or 3 insulin lispro daily injections) on lowering the blood sugar level

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

426 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Insulin lispro low mixture

Arm Type

Experimental

Arm Description

Insulin lispro low mixture (1, 2 or 3 daily injections)

Arm Title

Insulin glargine

Arm Type

Active Comparator

Arm Description

Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)

Intervention Type

Drug

Intervention Name(s)

Insulin lispro low mixture

Other Intervention Name(s)

LY275585[P]

Intervention Description

Dose depending on patient's need; subcutaneous injection before meal; start with once-daily injection before evening meal for 48 weeks, may add second injection before breakfast at any time during the treatment period if required, and may further add third injection before lunch at any time in the remainder of the treatment period if required.

Intervention Type

Drug

Intervention Name(s)

Insulin glargine

Intervention Description

Dose depending on patient's need; one daily subcutaneous injection before bedtime for 48 weeks

Intervention Type

Drug

Intervention Name(s)

Insulin lispro

Other Intervention Name(s)

LY275585

Intervention Description

Dose depending on patient's need; subcutaneous injection before meal; may start once-daily injection before meal (e.g. lunch if the highest blood glucose value is measured before dinner) on top of insulin glargine at any time of the treatment period if required, and may further add second or even third injection in the remainder of the treatment period if required.

Primary Outcome Measure Information:

Title

Change From Baseline to 48 Week Endpoint in Hemoglobin A1c (HbA1c)

Time Frame

Baseline, 48 weeks

Secondary Outcome Measure Information:

Title

Change in Hemoglobin A1c (HbA1c) Over Time

Time Frame

Baseline, 16 Weeks, 32 Weeks, 48 Weeks

Title

Percentage of Patients Achieving HbA1c <6.5% and <7% Over Time

Time Frame

16 weeks, 32 weeks, 48 weeks

Title

7-point Self-monitored Blood Glucose Profiles

Time Frame

Baseline, 16 weeks, 32 weeks, 48 weeks

Title

Change From Baseline in Postprandial Blood Glucose Over Time

Description

Time Frame

Baseline, 16 weeks, 32 weeks, 48 weeks

Title

Daily Total Insulin Dose (U/Day) at 16, 32, and 48 Weeks

Time Frame

16 weeks, 32 weeks, 48 weeks

Title

Daily Total Insulin Dose Per Body Weight (U/kg/Day) at 16, 32, and 48 Weeks

Time Frame

16 weeks, 32 weeks, 48 weeks

Title

Change From Baseline to 48 Week Endpoint in Lipid and Cholesterol Profiles

Time Frame

baseline, 48 weeks

Title

Safety: Number of Participants With Serious and Non-Serious Adverse Events

Description

Safety was assessed via serious adverse events (SAEs) and AEs, the details of which are listed in the Reported Adverse Event section.

Time Frame

baseline through 48 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Type 2 diabetes mellitus Receiving oral antihyperglycemic medications (including metformin) without insulin injection in the last 90 days Hemoglobin A1c (HbA1c) equal to or greater than 7.0% but less than 11.0% Willing to receive insulin injection while continuing to take the prestudy oral antihyperglycemic medications Able to perform self monitoring of blood glucose Exclusion Criteria: Are taking any other glucose-lowering agents other than metformin, sulfonylurea or Thiazolidinedione (Pioglitazone) Have taken acarbose, miglitol, pramlintide, exenatide, repaglinide, or nateglinide in the past 6 weeks, or for a total of 30 days or more, in the last 24 weeks Have a body mass index greater than 35 kg/m2 History or presence of kidney disease Have cardiac disease (Class III or IV)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

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.

City

Daw Park

State/Province

South Australia

ZIP/Postal Code

5041

Country

Australia

Facility Name

City

East Ringwood

State/Province

Victoria

ZIP/Postal Code

3135

Country

Australia

Facility Name

City

Nedlands

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

Facility Name

City

Belem

ZIP/Postal Code

66073-000

Country

Brazil

Facility Name

City

Campinas

ZIP/Postal Code

13073-350

Country

Brazil

Facility Name

City

Curitiba

ZIP/Postal Code

80060-900

Country

Brazil

Facility Name

City

Fortaleza

ZIP/Postal Code

60430-370

Country

Brazil

Facility Name

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T5J 3N4

Country

Canada

Facility Name

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3C 0N2

Country

Canada

Facility Name

City

Mississauga

State/Province

Ontario

ZIP/Postal Code

L5M 2V8

Country

Canada

Facility Name

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1N 6N5

Country

Canada

Facility Name

City

Charlottetown

State/Province

Prince Edward Island

ZIP/Postal Code

C1A 1L2

Country

Canada

Facility Name

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1G 5K2

Country

Canada

Facility Name

City

Beijing

ZIP/Postal Code

100053

Country

China

Facility Name

City

Guang Zhou

ZIP/Postal Code

510120

Country

China

Facility Name

City

Shanghai

ZIP/Postal Code

200433

Country

China

Facility Name

City

Aligarh

ZIP/Postal Code

202002

Country

India

Facility Name

City

Bangalore

ZIP/Postal Code

560052

Country

India

Facility Name

City

Coimbatore

Country

India

Facility Name

City

Mumbai

ZIP/Postal Code

400 007

Country

India

Facility Name

City

Trivandrum

ZIP/Postal Code

695029

Country

India

Facility Name

City

Kyunggi-Do

ZIP/Postal Code

425-020

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

139-872

Country

Korea, Republic of

Facility Name

City

Mexico City

ZIP/Postal Code

06700

Country

Mexico

Facility Name

City

Monterrey

ZIP/Postal Code

64570

Country

Mexico

12. IPD Sharing Statement

Citations:

PubMed Identifier

22672081

Citation

Bowering K, Reed VA, Felicio JS, Landry J, Ji L, Oliveira J. A study comparing insulin lispro mix 25 with glargine plus lispro therapy in patients with Type 2 diabetes who have inadequate glycaemic control on oral anti-hyperglycaemic medication: results of the PARADIGM study. Diabet Med. 2012 Sep;29(9):e263-72. doi: 10.1111/j.1464-5491.2012.03722.x. Erratum In: Diabet Med. 2012 Nov;29(11):1473. Felicio, J [corrected to Felicio, J S].

Results Reference

derived

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A Study for Type 2 Diabetic Patients

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