Primary outcomeMean· Baseline, Week 26
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26
| Group | Value (percentage of HbA1c) | Spread |
|---|---|---|
| Soliqua 100/33 | -1.86 | 0.96 |
| Lantus | -1.07 | 1.17 |
Trial · Interventional
TerminatedPhase 3Results postedRegistry dataEfficacy and Safety of Soliqua Versus Lantus in Ethnically/Racially Diverse Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin and Oral Antidiabetic Agents
Short name LixiLan-D
This trial was stopped early.
Reason given at the registry: ("Trial terminated (recruitment delays)")
Results were posted for this trial.
Overview
- Status
- Terminated
- Phase
- Phase 3
- Enrollment
- 241 participants (actual)
- Sponsor
- Sanofi · Industry
- Design
- Randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- 20 Feb 2018
- Primary completion
- 7 Jan 2019
- Completion
- 7 Jan 2019
- First posted
- 15 Feb 2018
- Last update posted
- 28 Mar 2022
- Conditions
- Type 2 Diabetes Mellitus
Timeline
1 trial · 1 stopped early · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201820192020
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Primary Objective: * To demonstrate the superiority of Soliqua 100/33 versus Lantus in the hemoglobin A1c (HbA1c) change within the overall population. * To demonstrate the benefit of Soliqua 100/33 versus Lantus in the HbA1c within each ethnic/racial subgroup evaluated (ie, Hispanics of any race, non-Hispanic black/African Americans and non-Hispanic Asians). Secondary Objective: * To assess the effects of Soliqua 100/33 versus Lantus on the secondary efficacy parameters within each ethnic/racial subgroup evaluated. * To assess the change in daily insulin glargine dose within each ethnic/racial subgroup. * To evaluate the safety and tolerability (e.g., gastrointestinal tolerability) of Soliqua 100/33 versus Lantus within each ethnic/racial subgroup.
Interventions
- Insulin glargine/LixisenatideDrug
- Insulin glargine (HOE901)Drug
- Background therapyDrug
Arms2
Experimental
Soliqua 100/33
Soliqua 100/33 (Insulin glargine/lixisenatide) once daily in the morning within 1 hour before breakfast, on top of oral anti-diabetic drug (OAD) therapy for 26 weeks.
Active comparator
Lantus
Lantus (Insulin glargine) once daily at any time of the day but at about the same time every day on top of OAD therapy for 26 weeks.
Primary outcomes1
Outcomes the sponsor listed as primary.
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26
Time frame · Baseline, Week 26
Registry description
Change in HbA1c was calculated by subtracting baseline value from Week 26 value.
Secondary outcomes(6)
Percentage of Participants Achieving HbA1c Target of <7% at Week 26
Time frame · Week 26
Registry description
Participants who had no available assessment for HbA1c at Week 26 were considered as non-responders.
Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Standardized Mixed Meal at Week 26
Time frame · Baseline, Week 26
Registry description
The 2-hour PPG test measured blood glucose 2 hours after eating a standardized breakfast meal.
Change From Baseline in 2-Hour Blood Glucose Excursion During Standardized Meal Test at Week 26
Time frame · Baseline, Week 26
Change From Baseline in Daily Insulin Glargine Dose at Week 26
Time frame · Baseline, Week 26
Registry description
Change in daily dose was calculated by subtracting baseline value from Week 26 value.
Change From Baseline in Body Weight at Week 26
Time frame · Baseline, Week 26
Registry description
Change in body weight was calculated by subtracting baseline value from Week 26 value.
Percentage of Participants With Hypoglycemic Events (Any Hypoglycemia, Severe Hypoglycemia, Documented Hypoglycemia) During the On-Treatment Period
Time frame · Baseline to Week 26
Registry description
Severe hypoglycemia was an event in which the participant required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Documented hypoglycemia with plasma glucose cut-off of \<=70 mg/dL (3.9 mmol/L) was any hypoglycemia documented by a measured plasma glucose \<=70 mg/dL (3.9 mmol/L) and excluding plasma glucose \<54 mg/dL regardless of symptoms. Documented hypoglycemia with plasma glucose cut-off of \<54 mg/dL (3.0 mmol/L) was any hypoglycemia documented by a measured plasma glucose \<54 mg/dL (3.0 mmol/L) regardless of symptoms.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(6)
Secondary outcomeNumber· Week 26
Percentage of Participants Achieving HbA1c Target of <7% at Week 26
| Group | Value (percentage of participants) |
|---|---|
| Soliqua 100/33 | 52.6 |
| Lantus | 30.8 |
Secondary outcome· Baseline, Week 26
Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Standardized Mixed Meal at Week 26
| Group | Value |
|---|---|
| Soliqua 100/33 | not posted |
| Lantus | not posted |
Secondary outcome· Baseline, Week 26
Change From Baseline in 2-Hour Blood Glucose Excursion During Standardized Meal Test at Week 26
| Group | Value |
|---|---|
| Soliqua 100/33 | not posted |
| Lantus | not posted |
Secondary outcomeMean· Baseline, Week 26
Change From Baseline in Daily Insulin Glargine Dose at Week 26
| Group | Value (International Units (IU)) | Spread |
|---|---|---|
| Soliqua 100/33 | 18.7 | 16.4 |
| Lantus | 14.1 | 16.5 |
Secondary outcomeMean· Baseline, Week 26
Change From Baseline in Body Weight at Week 26
| Group | Value (kilograms (kg)) | Spread |
|---|---|---|
| Soliqua 100/33 | 1.69 | 3.74 |
| Lantus | 1.52 | 2.92 |
Secondary outcomeNumber· Baseline to Week 26
Percentage of Participants With Hypoglycemic Events (Any Hypoglycemia, Severe Hypoglycemia, Documented Hypoglycemia) During the On-Treatment Period
| Group | Value (percentage of participants) |
|---|---|
| Soliqua 100/33 | 48.7 |
| Lantus | 52.8 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Soliqua 100/33Soliqua 100/33 (Insulin glargine/lixisenatide) once daily in the morning within 1 hour before breakfast, on top of OAD therapy for 26 weeks. | 0 / 115 | 7 / 115 | 21 / 115 |
| LantusLantus (Insulin glargine) once daily at any time of the day but at about the same time every day on top of OAD therapy for 26 weeks. | 0 / 125 | 4 / 125 | 20 / 125 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion criteria :
* Participants with type 2 diabetes mellitus (T2DM) diagnosed at least 1 year prior to the screening visit (signing of informed consent).
* Uncontrolled diabetes as demonstrated by a screening centrally measured hemoglobin A1c (HbA1c) between 7.5% and 10% (inclusive).
* Participants who were Hispanics of any race, non-Hispanic black/African Americans or non-Hispanic Asians. Note: Decision for ethnic/racial inclusion was made based on the participant's self-identification. Mixed-race participants must select 1 of the above-mentioned categories. If such selection could not be made, the candidate would be ineligible to participate in the study.
* Participants who had been treated with any basal insulin (ie, glargine - U100 or U300, detemir, degludec, intermediate-acting \[human Neutral Protamine Hagedorn (NPH\]) for at least 6 months prior to Visit 1.
* The basal insulin regimen (ie, type of insulin and time/frequency of the injection) had been stable for at least 3 months prior to Visit 1.
* The basal insulin dose had been stable (defined as up to ±20% \[1/5 of the dose\] variability) for at least 2 months prior to Visit 1 within the following dose ranges:
* 15 to 50 units/day if HbA1c at Visit 1 is less than or equal to (\<=)8.5%, and
* 15 to 40 units/day if HbA1c at Visit 1 is greater than (\>)8.5%.
* Participants receiving 1 or 2 of the following OAD drugs: metformin, pioglitazone/rosiglitazone, an sodium-glucose transport protein 2 (SGLT-2) inhibitor or a sulfonylurea (SU), at stable doses for at least 12 weeks prior to Visit 1.
Exclusion criteria:
* Age \<18 years of age at Visit 1.
* A body mass index (BMI) \<=20 or \>40 kg/m\^2 at Visit 1.
* Fasting plasma glucose (FPG) \>200 mg/dL (by central lab measurement) at Visit 1 (1-time repeat measurement before Visit 2 is permitted).
* Type 1 DM or any diabetes other than T2DM.
* Any use of OAD drugs other than those described in the inclusion criteria (e.g., but not limited to, glucagon like peptide-1 receptor agonist (GLP-1 RA), dipeptidyl peptidase 4 (DPP4) inhibitors) within 12 weeks prior Visit 1.
* Use of any other type of insulin except for basal insulin (e.g., prandial or premixed insulin, insulin pump) within 6 months prior to Visit 1. Note: History of short-term treatment (i.e, \<=10 days) with other insulin types due to intercurrent illness was permitted at the discretion of the Investigator.
* Known history of discontinuation of treatment with a GLP-1 RA due to safety/tolerability reasons.
* Use of systemic glucocorticoids for a total duration of \>7 days within 12 weeks prior to Visit 1.
* Initiation/change in type or dose of a weight loss drug within 12 weeks prior to Visit 1.
The above information is not intended to contain all considerations relevant to a participants's potential participation in a clinical trial.
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