Efficacy and Safety of Insulin Glargine/Lixisenatide Fixed Combination Versus Insulin Glargine Alone on Top of Metformin in Type 2 Diabetic Patients

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted at 70 centers in 13 countries. A total of 520 participants were screened between November 21, 2011 and June 08, 2012. Out of 520 participants, 197 were screen failure; main reason for screen failure was that glycosylated hemoglobin (HbA1c) values were out of the protocol defined range.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 323 participants were randomized in 1:1 ratio to insulin glargine/lixisenatide fixed ratio combination (FRC) and insulin glargine arms, stratified by screening HbA1c values (<8% or ≥8%) and screening body mass index (BMI) values (<30 kg/m^2, ≥30 kg/m^2).

Reporting Groups

	Description
Insulin Glargine/Lixisenatide Fixed Ratio Combination	FRC injected subcutaneously once daily (QD) for 24 weeks. Dose individually adjusted.
Insulin Glargine	Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.

Participant Flow:   Overall Study

	Insulin Glargine/Lixisenatide Fixed Ratio Combination	Insulin Glargine
STARTED	161	162
COMPLETED	150	159
NOT COMPLETED	11	3
Adverse Event	6	0
Poor compliance to protocol	1	1
Other reasons	4	2

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Insulin Glargine/Lixisenatide Fixed Ratio Combination	FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
Insulin Glargine	Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
Total	Total of all reporting groups

Baseline Measures

	Insulin Glargine/Lixisenatide Fixed Ratio Combination	Insulin Glargine	Total
Overall Participants Analyzed  [Units: Participants]	161	162	323
Age  [Units: Years] Mean (Standard Deviation)	56.9  (9.5)	56.6  (9.4)	56.7  (9.4)
Gender  [Units: Participants] Count of Participants
Female	81  50.3%	77  47.5%	158  48.9%
Male	80  49.7%	85  52.5%	165  51.1%
Race  [Units: Participants]
Caucasian/White	158	160	318
Black	2	1	3
Asian/Oriental	1	1	2
Ethnicity  [Units: Participants]
Hispanic	35	30	65
Non Hispanic	126	132	258
Screening HbA1c  [Units: Percentage of haemoglobin] Mean (Standard Deviation)	8.12  (0.80)	8.08  (0.77)	8.10  (0.78)
Baseline BMI  [Units: Kg/m^2] Mean (Standard Deviation)	32.24  (4.75)	32.02  (4.35)	32.13  (4.55)
Duration of Diabetes  [Units: Years] Mean (Standard Deviation)	6.29  (4.29)	7.10  (5.27)	6.69  (4.82)
Daily Dose of Metformin  [Units: Mg] Mean (Standard Deviation)	2075.8  (440.7)	2093.7  (415.5)	2084.8  (427.7)
Fasting Plasma Glucose (FPG)  [Units: mmol/L] Mean (Standard Deviation)	9.76  (2.19)	9.46  (2.16)	9.61  (2.18)

1.  Primary:

Change in HbA1c From Baseline to Week 24   [ Time Frame: Baseline, Week 24 ]

2.  Secondary:

Change in 2-hour Postprandial Plasma Glucose (PPG) From Baseline to Week 24   [ Time Frame: Baseline, Week 24 ]

3.  Secondary:

Change in 2-hour Plasma Glucose Excursion From Baseline to Week 24   [ Time Frame: Baseline, Week 24 ]

4.  Secondary:

Change in Average 7-Point Self-Monitored Plasma Glucose (SMPG) Profiles From Baseline to Week 24   [ Time Frame: Baseline, Week 24 ]

5.  Secondary:

Change in Body Weight From Baseline to Week 24   [ Time Frame: Baseline, Week 24 ]

6.  Secondary:

Average Daily Insulin Glargine Dose at Week 24   [ Time Frame: Week 24 ]

7.  Secondary:

Change in FPG From Baseline to Week 24   [ Time Frame: Baseline, Week 24 ]

8.  Secondary:

Percentage of Participants Requiring Rescue Therapy During 24-week Treatment Period   [ Time Frame: Baseline up to Week 24 ]

9.  Secondary:

Percentage of Participants With HbA1c ≤6.5 % or <7.0 % at Week 24   [ Time Frame: Week 24 ]

10.  Secondary:

Change in 30-minute and 1-hour PPG From Baseline to Week 24   [ Time Frame: Baseline, Week 24 ]

11.  Secondary:

Change in 30 Minute and 1-hour Plasma Glucose Excursion From Baseline to Week 24   [ Time Frame: Baseline, Week 24 ]

12.  Secondary:

Percentage of Participants Reaching HbA1c <7% at Week 24 With no Documented Symptomatic Hypoglycemia During 24-week Treatment Period   [ Time Frame: Baseline up to Week 24 ]

13.  Secondary:

Percentage of Participants Reaching HbA1c <7% With no Body Weight Gain at Week 24   [ Time Frame: Week 24 ]

14.  Secondary:

Percentage of Participants With Documented Symptomatic and Severe Symptomatic Hypoglycemia   [ Time Frame: First dose of study drug up to 3 days after the last dose administration (maximum of 219 days) ]

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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