Phase 3
Completed N=814
Safety and Efficacy of Albiglutide + Insulin Glargine Versus Insulin Lispro + Insulin Glargine Subjects With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT02229227 ↗Enrolled (actual)
814
Serious AEs
6.6%
Results posted
Jun 2018
Primary outcomePrimary: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 — -1.04; -1.10 Percentage of glycosylated hemoglobin — p=<0.0001
◆ Published Evidence
Established
67citations · ~11 / year
Impact of a Weekly Glucagon-Like Peptide 1 Receptor Agonist, Albiglutide, on Glycemic Control and on Reducing Prandial Insulin Use in Type 2 Diabetes Inadequately Controlled on Multiple Insulin Therapy: A Randomized Trial.
Summary
This Phase IIIb, randomized, open-label, parallel group, active control, multicenter, treat to-target study of 26 weeks' treatment duration will evaluate the efficacy and safety of once-weekly albiglutide as replacement of prandial insulin in subjects with type 2 diabetes mellitus (T2DM) failing to achieve adequate glycemic control on their current basal bolus insulin regimen (with or without metformin). Approximately 794 subjects will be randomly assigned in a 1:1 ratio to 1 of 2 treatment groups: albiglutide + insulin glargine (with insulin lispro discontinuation at Week 4) (with or without metformin) or to intensification of insulin glargine + insulin lispro (with or without metformin). The study will comprise 4 study periods : Screening (2 weeks), Standardization (4 weeks), Treatment (26 weeks), and Post treatment Follow up (4 weeks). The total duration of a subject's participation will be approximately 36 weeks.
Linked Publications
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Impact of a Weekly Glucagon-Like Peptide 1 Receptor Agonist, Albiglutide, on Glycemic Control and on Reducing Prandial Insulin Use in Type 2 Diabetes Inadequately Controlled on Multiple Insulin Therapy: A Randomized Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26 |
-1.04; -1.10 | <0.0001 sig |
| SECONDARY Number of Participants Treated With Once-weekly Albiglutide That Were Able to Discontinue Insulin Lispro at Week 4 and Did Not Meet Prespecified Criteria for Severe, Persistent Hyperglycemia Through Week 26 |
218 | — |
| SECONDARY Percentage of Participants With Severe or Documented Symptomatic Hypoglycemia Through Week 26 |
57.2; 75.0 | <0.0001 sig |
| SECONDARY Change From Baseline in Body Weight at Week 26 |
-1.95; 2.43 | <0.0001 sig |
| SECONDARY Change From Baseline to Week 26 in Body Weight |
-0.55; 0.66; -0.95; 0.85; -1.71; 1.46 | <0.0001 sig |
| SECONDARY Total Daily Insulin Dose at Week 26 |
70.36; 131.19 | <0.0001 sig |
| SECONDARY Change From Baseline to Week 26 in HbA1c |
-0.59; -0.47; -0.67; -0.58; -0.88; -0.96 | <0.0001 sig |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 |
-2.01; -1.46 | 0.0004 sig |
| SECONDARY Change From Baseline to Week 26 in FPG |
-1.30; -0.76; -1.07; -0.88; -1.76; -1.23 | 0.0004 sig |
| SECONDARY Number of Participants Achieving HbA1c <7.0% at Week 26 |
244; 255 | 0.7026 |
| SECONDARY Number of Participants Achieving HbA1c <7.0% up to Week 26 |
142; 139; 157; 182; 220; 261 | 0.2883 |
| SECONDARY Number of Participants Achieving a HbA1c <6.5% at Week 26 |
147; 169 | 0.2298 |
| SECONDARY Number of Participants Achieving a HbA1c <6.5% up to Week 26 |
39; 33; 63; 62; 116; 140 | 0.2143 |
| SECONDARY Number of Participants Who Met Prespecified Criteria for Severe, Persistent Hyperglycemia at Week 26 |
3; 3 | 0.8292 |
| SECONDARY Number of Participants Meeting Prespecified Criteria for Severe, Persistent Hyperglycemia up to Week 26 |
0; 0; 0; 0; 2; 0 | — |
| SECONDARY Total Daily Insulin Dose at Week 4, Week 10 and Week 18 |
50.53; 106.91; 57.99; 121.69; 68.23; 130.22 | — |
| SECONDARY Total Daily Basal Insulin (Insulin Glargine) at Week 4, 10, 18, and 26 Visits |
49.97; 50.94; 56.14; 55.79; 59.42; 59.18 | 0.7699 |
| SECONDARY Total Daily Bolus Insulin (Insulin Lispro) at Week 4, 10, 18, and 26 Visits |
0.62; 56.67; 1.90; 66.66; 8.89; 71.81 | <0.0001 sig |
| SECONDARY Total Number of Weekly Insulin Injections to Achieve Glycemic Control at Baseline/Randomization and Week 4, 10, 18, and 26 |
28.79; 28.00; 8.11; 28.00; 9.06; 28.00 | — |
| SECONDARY Percentage of Participants Achieving HbA1c <7.0% Without Weight Gain at Week 26 |
49.8; 21.4 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving HbA1c <7.0% Without Severe or Documented Symptomatic Hypoglycemia at Week 26 |
21.1; 9.5 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving HbA1c <7.0% Without Weight Gain and Without Severe or Documented Hypoglycemia at Week 26 |
15.9; 3.9 | <0.0001 sig |
| SECONDARY Number of Participants With On-therapy Adverse Events (AE) and Serious AE (SAE), and AE Leading to Discontinuation of Randomized Study Medication |
261; 254; 23; 31; 12; 6 | — |
| SECONDARY Number of Participants With Other AE of Special Interest |
305; 361; 7; 9; 102; 53 | — |
| SECONDARY Percentage of Participants With Events of Hypoglycemia With Confirmed Home Blood Glucose Monitoring and/or Third-party Intervention Through Week 26 |
55.3; 79.2; 60.3; 79.4; 1.8; 3.6 | — |
| SECONDARY Number of Participants With Hypoglycemic Events (in Total and by Each Category as Defined by the American Diabetes Association Criteria) |
9; 22; 203; 299; 230; 293 | — |
| SECONDARY Number of Participants With Daytime and Nocturnal Hypoglycemia |
288; 356; 155; 225; 6; 14 | — |
| SECONDARY Number of Participants With Hypoglycemia With Blood Glucose <56 Milligrams Per Deciliter (mg/dL) (<3.1 Millimoles Per Liter [mmol/L]), Regardless of Symptoms |
141; 239 | — |
| SECONDARY Number of Participants With Hematology Values of Clinical Concern |
5; 6; 9; 12; 9; 9 | — |
| SECONDARY Number of Participants With Clinical Chemistry Values of Clinical Concern |
12; 16; 0; 1; 9; 14 | — |
| SECONDARY Mean Urine Albumin/Creatinine Ratio at Week 0 and Week 26 |
14.40; 11.57; 10.37; 11.55 | — |
| SECONDARY Mean Albumin at Week 0 and Week 26 |
127.7; 108.2; 110.5; 146.3 | — |
| SECONDARY Mean Creatinine at Week 0 and Week 26 |
10646.3; 10663.8; 11364.6; 11394.2 | — |
| SECONDARY Mean Specific Gravity at Week 0 and Week 26 |
1.0182; 1.0180; 1.0180; 1.0186 | — |
| SECONDARY Number of Participants With Different Values of Potential of Hydrogen (pH) at Week 0 and Week 26 |
92; 107; 132; 132; 86; 77 | — |
| SECONDARY Number of Participants With Different Number of Erythrocytes in Urine at Week 0 and Week 26 |
119; 101; 34; 51; 9; 14 | — |
| SECONDARY Number of Participants With Different Number of Leukocytes in Urine at Week 0 and Week 26 |
69; 67; 27; 31; 20; 18 | — |
| SECONDARY Change From Baseline in Total Cholesterol (TC), Low-density Lipoprotein Cholesterol (LDL-c), High Density Lipoprotein (HDL-c), Triglycerides (TG) and Free Fatty Acids (FFA) at Week 10 and Week 26 |
-0.244; 0.041; -0.059; 0.073; -0.041; 0.016 | — |
| SECONDARY Number of Participants With Vital Signs of Clinical Concern |
21; 20; 27; 30; 1; 4 | — |
| SECONDARY Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Parameters |
18; 9; 4; 5 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female, 18 years of age or older (inclusive at the time of Screening) with T2DM
- HbA1c >= 7.0% and = 0.8 nanogram (ng) per milliliter (mL) [>= 0.26 nanomoles per litre (nmol/L)]
- Body mass index 2.5 × upper limit of normal (ULN) or bilirubin >1.5 × ULN (isolated bilirubin >1.5 × ULN is acceptable if bilirubin is fractionated and direct bilirubin 750 mg/dL at Screening
- Hemoglobinopathy that may affect proper interpretation of HbA1c
- Known allergy to albiglutide or any product components (including yeast and human albumin), any other GLP-1 analogue, insulin, or other study medication's excipients OR other contraindications (per the prescribing information) for the use of potential study medications (e.g., insulin glargine, insulin lispro)
- Use of oral or systemically injected glucocorticoids within the 3 months before randomization or high likelihood of a requirement for prolonged treatment (>1 week) in the 6 months following randomization. However, short courses of oral steroids (single dose or multiple doses for up to 7 days) may be permitted provided these cases are discussed with the medical monitor. Inhaled, intra-articular, epidural, and topical corticosteroids are allowed
- Female subject is pregnant (confirmed by laboratory testing) or lactating
- Receipt of any investigational drug within the 30 days or 5 half-lives, whichever is longer, before Screening, a history of receipt of an investigational antidiabetic drug within the 3 months before randomization, or receipt of albiglutide in previous studies
Data sourced from ClinicalTrials.gov (NCT02229227) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.