Phase 3
Completed N=350
Efficacy and Safety of Lixisenatide Versus Placebo on Top of Basal Insulin and/or Oral Antidiabetic Treatment in Older Type 2 Diabetic Patients
Source: ClinicalTrials.gov NCT01798706 ↗Enrolled (actual)
350
Serious AEs
5.1%
Results posted
Oct 2016
Primary outcomePrimary: Absolute Change in HbA1c From Baseline to Week 24 — -0.57; 0.06 percentage of hemoglobin — p=< 0.0001
◆ Published Evidence
Established
38citations · ~4 / year
Lixisenatide Therapy in Older Patients With Type 2 Diabetes Inadequately Controlled on Their Current Antidiabetic Treatment: The GetGoal-O Randomized Trial.
Summary
Primary objective:
- To evaluate the effect of lixisenatide versus placebo over a period of 24 weeks on glycemic control, as evaluated by glycosylated hemoglobin (HbA1c) reduction, in older type 2 diabetes participants (T2DM) who are inadequately controlled with their current anti-diabetic treatment regimen.
Main secondary objective:
- To assess the safety and tolerability of lixisenatide compared to placebo in older T2DM participants (including occurrence of documented (Plasma Glucose PG < 60 mg/dL) symptomatic hypoglycemia and gastrointestinal side effects).
Other secondary objectives:
* To assess the effect of lixisenatide compared to placebo after 24-week treatment on:
* Fasting plasma glucose (FPG);
* During liquid standardized breakfast meal challenge test : 2 hour- Postprandial Plasma Glucose (PPG) and Plasma Glucose Excursion;
* 7-point Self-monitored plasma glucose (SMPG) profile;
* Body weight;
* Change in total daily dose of basal insulin (if taken);
* Percentage of participants requiring rescue therapy
* Safety and tolerability;
* To assess lixisenatide pharmacokinetic profile;
* To assess anti-lixisenatide antibody development.
Linked Publications (2)
-
Lixisenatide Therapy in Older Patients With Type 2 Diabetes Inadequately Controlled on Their Current Antidiabetic Treatment: The GetGoal-O Randomized Trial.
-
Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change in HbA1c From Baseline to Week 24 |
-0.57; 0.06 | < 0.0001 sig |
| SECONDARY Change in 2-Hour PPG From Baseline to Week 24 |
-5.12; -0.07 | < 0.0001 sig |
| SECONDARY Change in Average 7-point SMPG Profiles From Baseline to Week 24 |
-1.15; -0.19 | < 0.0001 sig |
| SECONDARY Change in Body Weight From Baseline to Week 24 |
-1.47; -0.16 | < 0.0001 sig |
| SECONDARY Change in FPG From Baseline to Week 24 |
-0.3; 0.01 | 0.2347 |
| SECONDARY Percentage of Participants Requiring Rescue Therapy During 24 Week Treatment Period |
2.9; 10.4 | — |
| SECONDARY Change in Plasma Glucose Excursions From Baseline to Week 24 |
-4.71; -0.25 | — |
| SECONDARY Change in Total Daily Basal Insulin Dose From Baseline to Week 24 (in Participants Who Took Basal Insulin as Background Therapy) |
-2.97; -1.3 | — |
| SECONDARY Percentage of Participants With Symptomatic and Severe Symptomatic Hypoglycemia |
7.4; 5.7; 0.57; 0 | — |
| SECONDARY Percentage of Participants With HbA1c Reduction >0.5% at Week 24 and Did Not Experienced Documented (Plasma Glucose <60 mg/dL) Symptomatic Hypoglycemia |
57.6; 21.5 | — |
| SECONDARY Percentage of Participants With Gastrointestinal Disorders |
40.3; 20.7 | — |
Eligibility Criteria
Inclusion criteria
- Older participants, aged 70 years and above, with T2DM inadequately controlled on their current anti-diabetic pharmaceutical treatment regimen.
- Signed written informed consent.
Exclusion criteria
- At screening HbA1c ≤7.0% or >10% (Acknowledging that the threshold of 7% may not be appropriate for all older participants and that this was the responsibility of the investigator to include the participant based on an individual evaluation of the expected benefits of better glycemic control versus risk of hypoglycemia).
- At screening participants on both basal insulin and sulfonylurea or basal insulin and meglitinides.
- At screening FPG >250 mg/dL (>13.9 mmol/L).
- Type 1 diabetes mellitus or history of ketoacidosis within one year prior to the screening visit.
- Type 2 diabetes mellitus diagnosed less than 1 year prior to screening.
- Anti-diabetic treatment not at a stable regimen or initiated within the last 3 months prior to screening.
- Treatment within the 3 months preceding the screening with other anti-diabetic agent than allowed background therapy. Allowed therapy includes metformin, sulfonylurea (except glibenclamide >10mg, gliclazide >160mg), meglitinides (except repaglinide >6mg), pioglitazone and basal insulin and should follow local product circulars and labeling restrictions for the study population.
- Participants who had been on an approved or an investigational Glucagon-like peptide 1 (GLP-1) medication (exenatide, liraglutide, lixisenatide or others).
- History of severe hypoglycemia associated with symptoms unawareness or results in unconsciousness/coma/seizure in the 6 months prior to screening.
- BMI 40 kg/m^2.
- Malnutrition assessed clinically by the investigator or any sub-investigator and by Mini-Nutritional Assessment-Short Form (MNA-SF) score 3 times the upper limit of the normal (ULN) laboratory range
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times ULN
- Calcitonin >20 pg/mL (5.9 pmol/L).
- Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to): gastroparesis, unstable (i.e. worsening) and not controlled (i.e. prolonged nausea and vomiting) gastroesophageal reflux disease within 6 months prior to screening.
- History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease.
- Personal or immediate family history of medullary thyroid cancer or genetic conditions that predisposed to medullary thyroid cancer (e.g., multiple endocrine neoplasia syndromes).
The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Data sourced from ClinicalTrials.gov (NCT01798706) 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.