GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3Results posted

Comparison of Two Basal Insulins for Patients With Type 2 Diabetes Taking Oral Diabetes Medicines and Exenatide

A Randomized Trial Comparing Insulin Lispro Protamine Suspension With Insulin Glargine in Subjects With Type 2 Diabetes on Oral Antihyperglycemic Medications and Exenatide

Lead sponsor

Eli Lilly and Company

Asset

Exenatide

GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

339

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c ≥7%

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00560417

Org study ID11647

Secondary IDF3Z-US-IOPBEli Lilly and Company

Timeline

Milestones

Study first posted2007-11-19estimated

Results first posted2010-12-14estimated

Last update posted2011-01-13estimated

Study start2007-11 (month precision)

Primary completion2009-12actual (month precision)

Study completion2009-12actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age74 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Must have type 2 diabetes

•Must be at least 18 years of age and less than 75 years of age

•Must be taking exenatide 10 micrograms twice a day (BID) for at least 3 months

•Must be taking one of the following oral diabetes medication regimens for at least 3 months: (1) metformin (2) metformin + sulfonylurea (3) metformin + thiazolidinedione (TZD). Doses must be at or above the following: Metformin--1500 mg/day, Sulfonylurea--1/2 the maximum daily dose according to the product label, TZD--30 mg/day pioglitazone

•Must have a hemoglobin A1C greater than or equal to 7.0% and less than or equal to 10.0%

Exclusion criteria

•Must not have used insulin on a regular basis during the past 2 years

•Must not have taken any glucose-lowering medications not included in the inclusion criteria in the past 3 months

•Must not have had more than one episode of severe hypoglycemia in the past 6 months

•Must not have clinically significant hematologic, oncologic, renal, cardiac, hepatic, or gastrointestinal disease

•Must not be pregnant or intend to get pregnant during the course of the study

Endpoints (11)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Weight & body composition

Safety / tolerability / PK

Weight & body composition

2 endpoints

Secondary/protocol endpoint

Actual Body Weight at Baseline and Endpoint (LOCF)

Time frame:Baseline, Endpoint (LOCF) up to 24 weeks

descriptive

Posted result

Group	Value (mean), kilograms	95% CI
ILPSBaseline	101.57	—
Endpoint	101.85	—
GlargineBaseline	102.62	—
Endpoint	103.28	—

p0.343ANCOVA

Secondary/protocol endpoint

Change From Baseline in Body Weight at Endpoint (LOCF)

Time frame:Baseline, Endpoint (LOCF) up to 24 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), kilograms	95% CI
ILPS	0.27	—
Glargine	0.66	—

p0.417t-test, 2 sided

p0.041t-test, 2 sided

Mean Difference (Final Values)-0.3895% CI-1.15 – 0.40p0.343ANOVA

Glycemic / diabetes

7 endpoints

Primary/protocol endpoint

Change From Baseline in Hemoglobin A1C (HbA1c) at Endpoint (Last Observation Carried Forward [LOCF])

Time frame:Baseline, Endpoint (LOCF) up to 24 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percent of glycosylated hemoglobin	95% CI
ILPSBaseline	8.48	—
Endpoint (LOCF) Change	-1.21	—
GlargineBaseline	8.47	—
Endpoint (LOCF) Change	-1.43	—

Mean Difference (Final Values)0.2295% CI0.06 – 0.38ANCOVA

Secondary/protocol endpoint

Actual Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)

Time frame:24 weeks, Endpoint (LOCF) up to 24 weeks

descriptive, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percent of glycosylated hemoglobin	95% CI
ILPS24 weeks	6.94	—
Endpoint (LOCF)	7.00	—
Glargine24 weeks	6.70	—
Endpoint (LOCF)	6.78	—

Mean Difference (Final Values)0.2495% CI0.08 – 0.39p0.003ANCOVA

Mean Difference (Final Values)0.2295% CI0.06 – 0.38p0.008ANCOVA

Secondary/protocol endpoint

Change From Baseline in Hemoglobin A1C at 24 Weeks and Endpoint (LOCF)

Time frame:Baseline, 24 Weeks, Endpoint (LOCF) up to 24 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), percent of glycosylated hemoglobin	95% CI
ILPSBaseline	8.48	—
24 Weeks Change	-1.25	—
Endpoint (LOCF) Change	-1.21	—
GlargineBaseline	8.47	—
24 Weeks Change	-1.49	—
Endpoint (LOCF) Change	-1.43	—

Mean Difference (Final Values)0.2495% CI0.08 – 0.39p0.003ANCOVA

Mean Difference (Final Values)0.2295% CI0.06 – 0.38p0.008ANCOVA

Secondary/protocol endpoint

Percentage of Participants With Hemoglobin A1C Less Than 7.0% and Hemoglobin A1C Less Than or Equal to 6.5%

Time frame:Weeks 12, 18, 24 and Endpoint (LOCF) up to 24 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), percent of participants	95% CI
ILPSWeek 12: HbA1c <7.0%	46.9	—
Week 12: HbA1c <=6.5%	24.8	—
Week 18: HbA1c <7.0%	54.8	—
Week 18: HbA1c <=6.5%	30.8	—
Week 24: HbA1c <7.0%	55.4	—
Week 24: HbA1c <=6.5%	29.7	—
Endpoint (LOCF): HbA1c <7.0%	53.7	—
Endpoint (LOCF): HbA1c <=6.5%	28.4	—
GlargineWeek 12: HbA1c <7.0%	50.7	—
Week 12: HbA1c <=6.5%	28.7	—
Week 18: HbA1c <7.0%	69.1	—
Week 18: HbA1c <=6.5%	37.6	—
Week 24: HbA1c <7.0%	63.4	—
Week 24: HbA1c <=6.5%	39.9	—
Endpoint (LOCF): HbA1c <7.0%	61.7	—
Endpoint (LOCF): HbA1c <=6.5%	38.9	—

p0.561Fisher Exact

p0.511Fisher Exact

p0.012Fisher Exact

p0.269Fisher Exact

p0.161Fisher Exact

p0.071Fisher Exact

p0.177Fisher Exact

p0.060Fisher Exact

Secondary/protocol endpoint

7-Point Self-Monitored Blood Glucose (SMBG) Profiles at Baseline and Endpoint (LOCF)

Time frame:Baseline, Endpoint (LOCF) up to 24 weeks

descriptive, improvement

Posted result

Group	Value (mean), milligrams per deciliter (mg/dL)	95% CI
ILPSBaseline Morning Pre-Meal	175.41	—
Baseline Morning Postprandial	195.31	—
Baseline Midday Pre-Meal	165.18	—
Baseline Midday Postprandial	193.22	—
Baseline Evening Pre-Meal	173.33	—
Baseline Evening Postprandial	189.00	—
Baseline 0300 Hours	170.51	—
Baseline Daily Mean 7-Point Blood Glucose	180.19	—
Baseline Daily Mean Pre-Meal	170.60	—
Baseline Daily Mean Postprandial	192.37	—
Endpoint Morning Pre-Meal	129.63	—
Endpoint Morning Postprandial	152.32	—
Endpoint Midday Pre-Meal	132.84	—
Endpoint Midday Postprandial	161.77	—
Endpoint Evening Pre-Meal	146.03	—
Endpoint Evening Postprandial	159.14	—
Endpoint 0300 Hours	123.96	—
Endpoint Daily Mean 7-Point Blood Glucose	143.06	—
Endpoint Daily Mean Pre-Meal	135.51	—
Endpoint Daily Mean Postprandial	158.10	—
GlargineBaseline Morning Pre-Meal	180.86	—
Baseline Morning Postprandial	190.84	—
Baseline Midday Pre-Meal	166.34	—
Baseline Midday Postprandial	200.25	—
Baseline Evening Pre-Meal	175.14	—
Baseline Evening Postprandial	184.92	—
Baseline 0300 Hours	172.00	—
Baseline Daily Mean 7-Point Blood Glucose	180.72	—
Baseline Daily Mean Pre-Meal	172.66	—
Baseline Daily Mean Postprandial	191.27	—
Endpoint Morning Pre-Meal	127.01	—
Endpoint Morning Postprandial	137.39	—
Endpoint Midday Pre-Meal	129.71	—
Endpoint Midday Postprandial	155.26	—
Endpoint Evening Pre-Meal	135.93	—
Endpoint Evening Postprandial	144.25	—
Endpoint 0300 Hours	127.53	—
Endpoint Daily Mean 7-Point Blood Glucose	136.17	—
Endpoint Daily Mean Pre-Meal	129.32	—
Endpoint Daily Mean Postprandial	146.12	—

Mean Difference (Final Values)4.2895% CI-1.97 – 10.53p0.179ANCOVA

Mean Difference (Final Values)13.9695% CI5.72 – 22.19p<0.001ANCOVA

Mean Difference (Final Values)3.8095% CI-3.79 – 11.39p0.325ANCOVA

Mean Difference (Final Values)8.7395% CI-0.04 – 17.50p0.051ANCOVA

Mean Difference (Final Values)10.9295% CI3.66 – 18.19p0.003ANCOVA

Mean Difference (Final Values)14.1995% CI5.44 – 22.94p0.002ANCOVA

Mean Difference (Final Values)-3.0395% CI-10.35 – 4.28p0.415ANCOVA

Mean Difference (Final Values)7.3995% CI1.46 – 13.32p0.015ANCOVA

Mean Difference (Final Values)7.1295% CI1.10 – 13.14p0.021ANCOVA

Mean Difference (Final Values)11.9795% CI5.01 – 18.93p<0.001ANCOVA

Secondary/protocol endpoint

Glycemic Variability at Baseline and Endpoint (LOCF)

Time frame:Baseline, Endpoint (LOCF) up to 24 weeks

change from baseline, improvement

Posted result

Group	Value (mean), mg/dL	95% CI
ILPSBaseline	41.15	—
Endpoint	36.78	—
GlargineBaseline	39.02	—
Endpoint	30.96	—

Mean Difference (Final Values)2.2795% CI-0.68 – 5.22p0.131ANOVA

Mean Difference (Final Values)5.9995% CI2.82 – 9.16p<0.001ANOVA

Secondary/protocol endpoint

Total Daily Insulin Dose at Endpoint (LOCF)

Time frame:Endpoint (LOCF) up to 24 weeks

descriptive, improvement

Posted result

Group	Value (mean), Units of Insulin	95% CI
ILPS	31.11	—
Glargine	37.93	—

p<0.001ANOVA

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Incidence of Self-reported Hypoglycemic Episodes (All, Non-Nocturnal, Nocturnal, and Severe)

Time frame:Baseline to Endpoint (LOCF) up to 24 weeks

Documented hypoglycemia

event count, event

Posted result

Group	Value (number), percentage of participants	95% CI
ILPSAll Reported - Endpoint	41.8	—
All Reported - Overall	70.6	—
Non-Nocturnal - Endpoint	30.6	—
Non-Nocturnal - Overall	62.4	—
Nocturnal - Endpoint	21.8	—
Nocturnal - Overall	47.6	—
Severe - Endpoint	0	—
Severe - Overall	1.8	—
GlargineAll Reported - Endpoint	43.1	—
All Reported - Overall	74.9	—
Non-Nocturnal - Endpoint	40.1	—
Non-Nocturnal - Overall	70.7	—
Nocturnal - Endpoint	11.4	—
Nocturnal - Overall	37.1	—
Severe - Endpoint	0	—
Severe - Overall	0	—

p0.826Fisher Exact

p0.394Fisher Exact

p0.070Fisher Exact

p0.133Fisher Exact

p0.013Fisher Exact

p0.061Fisher Exact

p0.248Fisher Exact

Secondary/protocol endpoint

Rate of All, Non-Nocturnal, and Nocturnal Self-Reported Hypoglycemic Episodes (Adjusted for One Year)

Time frame:Baseline to Endpoint (LOCF) up to 24 weeks

Documented hypoglycemia

event count, event

Posted result

Group	Value (mean), episodes/participant/365 days	95% CI
ILPSAll reported episodes rate - Endpoint	14.51	—
All reported episodes rate - Overall	16.27	—
Non-Nocturnal reported episodes rate - Endpoint	10.40	—
Non-Nocturnal reported episodes rate - Overall	11.36	—
Nocturnal reported episodes rate - Endpoint	4.01	—
Nocturnal reported episodes rate - Overall	4.88	—
GlargineAll reported episodes rate - Endpoint	15.29	—
All reported episodes rate - Overall	18.05	—
Non-Nocturnal reported episodes rate - Endpoint	13.20	—
Non-Nocturnal reported episodes rate - Overall	14.83	—
Nocturnal reported episodes rate - Endpoint	1.73	—
Nocturnal reported episodes rate - Overall	3.01	—

p0.628Negative Binomial regression model

p0.570Negative Binomial regression model

p0.116Negative Binomial regression model

p0.044Negative Binomial regression model

p0.006Negative Binomial regression model

p0.004Negative Binomial regression model

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.