Phase 3
Completed N=446
24-week Treatment With Lixisenatide in Type 2 Diabetes Insufficiently Controlled With Metformin and Insulin Glargine
Source: ClinicalTrials.gov NCT00975286 ↗Enrolled (actual)
446
Serious AEs
6.1%
Results posted
Oct 2016
Primary outcomePrimary: Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 — -0.40; -0.71 percentage of hemoglobin — p=<0.0001
◆ Published Evidence
Highly cited
251citations · ~19 / year
Adding once-daily lixisenatide for type 2 diabetes inadequately controlled with newly initiated and continuously titrated basal insulin glargine: a 24-week, randomized, placebo-controlled study (GetGoal-Duo 1).
Summary
The purpose of the study is to evaluate the benefits and risks of lixisenatide (AVE0010), in comparison to placebo, as an add-on treatment to insulin glargine and metformin with or without thiazolidinediones (TZDs), over a period of 24 weeks of treatment.
The primary objective is to assess the effects of lixisenatide in comparison to placebo, when added to insulin glargine and metformin, on glycemic control in terms of glycosylated hemoglobin (HbA1c) reduction (absolute change) at Week 24.
The secondary objectives are to assess the effects of lixisenatide on the percentage of patients reaching HbA1c less than (<) 7 percent (%) and less than or equal to (<=) 6.5%, plasma glucose (fasting, postprandial during a standardized meal challenge test, 7-point self monitored profiles), body weight, insulin glargine doses, to evaluate safety and tolerability (including anti-lixisenatide antibody assessment), and to assess the impact on treatment satisfaction using the Diabetes Treatment Satisfaction Questionnaire (state) (DTSQs) in the participating countries where it is validated.
Linked Publications (5)
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Adding once-daily lixisenatide for type 2 diabetes inadequately controlled with newly initiated and continuously titrated basal insulin glargine: a 24-week, randomized, placebo-controlled study (GetGoal-Duo 1).
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Lixisenatide plus basal insulin in patients with type 2 diabetes mellitus: a meta-analysis.
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Propensity-score-matched comparative analyses of simultaneously administered fixed-ratio insulin glargine 100 U and lixisenatide (iGlarLixi) vs sequential administration of insulin glargine and lixisenatide in uncontrolled type 2 diabetes.
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Achieving postprandial glucose control with lixisenatide improves glycemic control in patients with type 2 diabetes on basal insulin: a post-hoc analysis of pooled data.
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Impact of Type 2 Diabetes Duration on the Efficacy and Safety of Add-on Lixisenatide in Asian Individuals Receiving Basal Insulin: A Pooled Analysis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 |
-0.40; -0.71 | <0.0001 sig |
| SECONDARY Change From Baseline in 2-Hour Postprandial Plasma Glucose (PPG) at Week 24 |
0.08; -3.09 | — |
| SECONDARY Change From Baseline in Glucose Excursion at Week 24 |
-0.33; -3.42 | — |
| SECONDARY Change From Baseline in Average 7-Point Self Monitored Plasma Glucose (SMPG) Profile at Week 24 |
-0.08; -0.47 | — |
| SECONDARY Change From Baseline in Body Weight at Week 24 |
1.16; 0.28 | — |
| SECONDARY Change From Baseline in Average Insulin Glargine Daily Dose at Week 24 |
5.34; 3.10 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 |
0.46; 0.34 | — |
| SECONDARY Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than 7% at Week 24 |
38.5; 56.3 | — |
| SECONDARY Percentage of Patients With Glycosylated Hemoglobin (HbA1c) Level Less Than or Equal to 6.5% at Week 24 |
16.3; 32.1 | — |
| SECONDARY Percentage of Patients Requiring Rescue Therapy During the Double-blind Period |
0.4; 0.4 | — |
| SECONDARY Change From Baseline in Treatment Satisfaction Score (Sum of Items 1, 4, 5, 6, 7 and 8 of DTSQ) at Week 24 |
0.65; 0.88 | — |
Eligibility Criteria
Inclusion criteria
- Type 2 diabetes mellitus, diagnosed for at least 1 year before screening visit, insufficiently controlled with insulin glargine and metformin
Exclusion criteria
- HbA1c )10% at screening
- At the time of screening age 180 millimeter of mercury (mmHg) or >110 mmHg, respectively
- Laboratory findings at the time of screening: amylase and/or lipase, alanine aminotransferase >3 times upper limit of the normal (ULN) laboratory range; total bilirubin: >1.5 times ULN (except in case of Gilbert's syndrome); hemoglobin =20 picogram per milliliter (pg/mL) (5.9 picomole per milliliter [pmol/L])
- Patients who are considered by the Investigator or any sub investigator as inappropriate for this study for any reason (for example, impossibility to meet specific protocol requirements, such as scheduled visits, being able to do self-injections, likelihood of requiring treatment during the screening phase and treatment phase with drugs not permitted by the clinical study protocol, patient being investigator or any sub investigator, pharmacist, study coordinator, other study staff or relative thereof directly involved in the conduct of the protocol etc.)
- Use of systemic glucocorticoids (excluding topical application or inhaled forms) for one week or more within 3 months prior to the time of screening
- Use of any investigational drug within 3 months prior to screening
- Renal impairment defined with serum creatinine > 1.4 mg/dL in women and > 1.5 mg/dL in men
- History of hypersensitivity to insulin glargine or to any of the excipients
- Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to): gastroparesis, unstable (that is, worsening) and not controlled (that is, prolonged nausea and vomiting) gastroesophageal reflux disease requiring medical treatment, within 6 months prior to the time of screening
- Any previous treatment with lixisenatide (for example, participation in a previous study with lixisenatide)
- Allergic reaction to any GLP-1 receptor agonist in the past (for example, exenatide, liraglutide) or to metacresol
- Additional exclusion criteria during or at the end of the run-in phase before randomization: informed consent withdrawal (patient who was not willing to continue or failed to return), mean fasting SMPG calculated from the self-measurements for the 7 days prior to Visit 12 (Week -1) was >140 mg/dL (7.8 mmol/L) and HbA1c measured at Visit 12 (Week -1) is 9%, amylase and/or lipase > 3 times the ULN at Visit 12 (Week -1), patients with fasting plasma glucose (FPG) above the threshold value described for rescue (that is, FPG >240 mg/dL [13.3 mmol/L]), patients with any adverse event, which, by the judgment of the Investigator precludes the inclusion in the double-blind randomized treatment phase, and lack of compliance to protocol or to insulin glargine treatment during the run-in phase
Data sourced from ClinicalTrials.gov (NCT00975286) 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.