Phase 3 · Exenatide

NCT01554618 trial results

A Phase 3, Double-Blind, Placebo-Controlled, Randomized, Multi-Center Study to Assess the Safety and Efficacy of Exenatide Once Weekly in Adolescents With Type 2 Diabetes

Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) to Week 24 (Controlled Assessment Period) (percentage (% HbA1c)), Baseline (Week 0) and Week 24. Controlled Assessment Period - Exenatide: -0.36; Controlled Assessment Period - Placebo: 0.49.

Participants
84
Status
completed
Completed
2021-05-05
Sponsor
AstraZeneca

As posted on ClinicalTrials.gov (NCT01554618), updated at source Nov 30, 2021. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT01554618 measured first

Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) to Week 24 (Controlled Assessment Period)percentage (% HbA1c) · Baseline (Week 0) and Week 24 · least squares mean
Controlled Assessment Period - Exenatiden=58Controlled Assessment Period - Placebon=24
-0.36(0.184)0.49(0.273)
Percentage of Patients With On-Treatment Adverse Events (AEs) up to Week 24 (Controlled Assessment Period)percentage of participants · Day 1 (Week 0) up to Week 24, plus up to a maximum of 90 days follow up · number
MeasureControlled Assessment Period - Exenatiden=59Controlled Assessment Period - Placebon=23
Any AE61.073.9
Any AE with outcome of death00
Any SAE3.44.3
Any AE leading to discontinuation of treatment00
Any AE leading to discontinuation from study00
Any AE related to treatment25.421.7
Percentage of Patients Positive for Anti-Drug Antibodies (ADAs) to Exenatide up to Week 24percentage of participants · Samples were collected on Day 1 (Week 0), Week 4, Week 8, Week 12 and Week 24 · number
MeasureTreatment Period - Exenatiden=59
Week 4: High Positive17.0
Week 4: Low Positive30.2
Week 4: Treatment-Emergent ADA Positive45.3
Week 8: High Positive53.8
Week 8: Low Positive38.5
Week 8: Treatment-Emergent ADA Positive92.3
Week 12: High Positive60.0
Week 12: Low Positive38.0
Week 12: Treatment-Emergent ADA Positive98.0
Week 24: High Positive40.8
Week 24: Low Positive55.1
Week 24: Treatment-Emergent ADA Positive95.9
Side effects by arm

Side effects in NCT01554618

Percent of participants affected, After the first dose of study medication in period through the end of the treatment in period + 90 days for SAEs (or + 7 days for non-serious (i.e. Other) AEs. Overall time frame: up to maximum of.... The most common events the registry lists.

EventControlled Assessment Period - ExenatideControlled Assessment Period - PlaceboExtension Period - ExenatideExtension Period - Placebo to Exenatide
Any serious event3.4%4.3%6%4.5%
Abdominal pain3.4%13%2%0%
Upper respiratory tract infection10.2%0%4%0%
Hyperglycaemia1.7%4.3%0%9.1%
Cough6.8%4.3%0%9.1%
Nasopharyngitis6.8%8.7%2%4.5%
Urinary tract infection5.1%8.7%0%0%
Headache6.8%8.7%4%4.5%
Diarrhoea8.5%4.3%2%0%
Nausea6.8%4.3%0%4.5%
Abdominal pain upper5.1%0%2%0%
Vomiting5.1%0%4%0%
Injection site erythema5.1%4.3%0%0%
Hypoglycaemia5.1%0%2%0%
Pain in extremity5.1%0%0%0%
Secondary outcomes

What else it measured

Change From Baseline in Fasting Plasma Glucose (FPG) Concentration to Week 24 (Controlled Assessment Period)milligrams per deciliter (mg/dL) · Baseline (Week 0) and Week 24 · least squares mean
Controlled Assessment Period - Exenatiden=58Controlled Assessment Period - Placebon=24
-5.2(7.65)16.5(11.32)
Change From Baseline in Body Weight to Week 24 (Controlled Assessment Period)kilogram (kg) · Baseline (Week 0) and Week 24 · least squares mean
Controlled Assessment Period - Exenatiden=58Controlled Assessment Period - Placebon=24
-0.59(0.665)0.63(0.982)
Change From Baseline in Fasting Insulin to Week 24 (Controlled Assessment Period)picomoles per liter (pmol/L) · Baseline (Week 0) and Week 24 · least squares mean
Controlled Assessment Period - Exenatiden=58Controlled Assessment Period - Placebon=24
79.6(52.28)-15.3(78.49)
Percentage of Patients Achieving HbA1c Goals of < 6.5%, ≤ 6.5%, and < 7.0% at Week 24 (Controlled Assessment Period)percentage of participants · At Week 24 · number
MeasureControlled Assessment Period - Exenatiden=48Controlled Assessment Period - Placebon=22
HbA1c <6 .5%19.0(8.9 to 29.1)4.2(0.0 to 12.2)
HbA1c ≤ 6.5%19.0(8.9 to 29.1)4.2(0.0 to 12.2)
HbA1c < 7.0%31.0(19.1 to 42.9)8.3(0.0 to 19.4)
Change From Baseline in Lipid Profiles to Week 24 (Controlled Assessment Period)millimoles per liter (mmol/L) · Baseline (Week 0) and Week 24 · mean
MeasureControlled Assessment Period - Exenatiden=58Controlled Assessment Period - Placebon=24
Total Cholesterol-0.117(0.7124)-0.114(0.5819)
HDL-C-0.035(0.1950)-0.047(0.1039)
LDL-C-0.050(0.5618)-0.110(0.5983)
Triglycerides-0.122(1.0303)0.094(0.6626)
Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) to Week 24 (Controlled Assessment Period)millimeters mercury (mmHg) · Baseline (Week 0) and Week 24 · least squares mean
MeasureControlled Assessment Period - Exenatiden=58Controlled Assessment Period - Placebon=24
SBP-0.7(1.48)2.2(2.15)
DBP0.2(1.00)-1.3(1.45)
Number of Patients Needing Rescue Medication Due to Failure to Maintain Glycemic Control up to Week 24 (Controlled Assessment Period)Participants · At Week 4, Week 8, Week 12, Week 18 and Week 24 · count of participants
MeasureControlled Assessment Period - Exenatiden=58Controlled Assessment Period - Placebon=24
Week 400
Week 800
Week 1200
Week 1810
Week 2400
Change From Baseline in Homeostasis Model Assessments - Beta-Cell Function (HOMA-B) and Insulin Sensitivity (HOMA-S) to Week 24 (Controlled Assessment Period)percentage (%HOMA-B and %HOMA-S) · Baseline (Week 0) and Week 24 · least squares mean
MeasureControlled Assessment Period - Exenatiden=14Controlled Assessment Period - Placebon=7
HOMA-B63.98(39.552)-26.39(56.138)
HOMA-S0.62(3.607)7.37(4.914)
Percentage of Patients Reporting AEs of Injection Site Reactions up to Week 24 (Controlled Assessment Period)percentage of participants · At Week 4, Week 8, Week 12, Week 18 and Week 24 · number
MeasureControlled Assessment Period - Exenatiden=59Controlled Assessment Period - Placebon=23
Week 48.58.7
Week 83.54.3
Week 121.90
Week 1800
Week 2400
Change From Baseline in HbA1c to Week 52 Among Patients Who Received Open-Label Exenatide (Treatment Period)percentage (% HbA1c) · Baseline (Week 0) and Week 52 · mean
Treatment Period - Exenatiden=39Treatment Period - Placebo Then Exenatiden=17
-0.10(1.711)0.53(2.123)
Change From Baseline in FPG Concentration to Week 52 Among Patients Who Received Open-Label Exenatide (Treatment Period)mg/dL · Baseline (Week 0) and Week 52 · mean
Treatment Period - Exenatiden=38Treatment Period - Placebo Then Exenatiden=16
-1.8(62.64)10.6(75.49)
Change From Baseline in Body Weight to Week 52 Among Patients Who Received Open-Label Exenatide (Treatment Period)kg · Baseline (Week 0) and Week 52 · mean
Treatment Period - Exenatiden=39Treatment Period - Placebo Then Exenatiden=18
0.04(6.088)-0.04(4.687)
The trial

How NCT01554618 was run

The study examines the Safety and efficacy study of exenatide once weekly in children and adolescents with type 2 diabetes

  • EQW: Exenatide once weekly
  • Placebo: Placebo once weekly
Who could join the trial

Each patient must meet the following criteria to be enrolled in this study. 1. Is a child or an adolescent of 10 to \<18 years old, at Visit 1 (Screening) 2. Has been diagnosed with type 2 diabetes mellitus per American Diabetes Association diagnostic criteria 3. HbA1c of 6.5% to 11.0%, inclusive, in patients not taking insulin/SU, and of 6.5% to 12.0%, inclusive, in patients taking insulin/SU, at Visit 1 (Screening) 4. Has a C-peptide of \>0.6 ng/L at Visit 1 (Screening) 5. Has been treated with diet and exercise alone or in combination with a stable dose of an oral antidiabetic agent (e.g., metformin and/or SU) and/or insulin for their type 2 diabetes for at least 2 months prior to Visit 1 (Screening) 6. Has a fasting plasma glucose concentration \<280 mg/dL (15.5 mmol/L) at Visit 1 (Screening) Patients who meet any of the following criteria will be excluded from the study. 1. Has a clinically significant medical condition that could potentially affect study participation and/or personal well-being, as judged by the Investigator, including but not limited to the following conditions: 1. Hepatic disease (defined by aspartate or alanine transaminase \>3.0 times the upper limit of normal (ULN) 2. Renal disease or serum creatinine \>1.5 mg/dL (132.6 µmol/L) (males) or 1.4 mg/dL (123.8 µmol/L) (females) 3. Gastrointestinal disease deemed significant by the Investigator 4. Organ transplantation 5. Chronic infection (e.g., tuberculosis, human immunodeficiency virus, hepatitis B virus, or hepatitis C virus) 6. Clinically significant malignant disease (with the exception of basal and squamous cell carcinoma of the skin) within 5 years of Visit 1 (Screening) 2. Has positive antibody titers to glutamic acid decarboxylase (GAD65) or islet cell antigen (ICA512) at Visit 1 (Screening) 3. Has a personal or family history of elevated calcitonin, calcitonin \>100 ng/L, medullary thyroid carcinoma, or multiple endocrine neoplasia-2 4. Has ever used exenatide (exenatide once weekly \[exenatide LAR\], exenatide BID, BYETTA, or any other formulation) or any glucagon-like peptide-1 (GLP-1) receptor agonist (e.g., liraglutide \[Victoza®\]) 5. Is pregnant

Published papers

Papers from NCT01554618

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

GLPcompare is an informational data platform, not a medical provider or pharmacy. Nothing here is medical advice, a diagnosis, or a recommendation to start, stop, or change any treatment. Data is aggregated from public sources and can be incomplete or out of date. Always confirm with a licensed clinician and the current FDA label.