Brief Summary

The primary objective was to demonstrate the superiority of insulin glargine over sitagliptin in reducing Glycosylated Hemoglobin A1c (HbA1c) from baseline to the end of the treatment period. Secondary objective was to assess the effect of insulin glargine in comparison with sitagliptin on:

HbA1c level
Fasting Plasma Glucose (FPG)
7-point plasma glucose (PG) profiles
Percentage of patients with HbA1c \<7% and \<6.5% Safety objectives consisted of:
Hypoglycemia occurrence
Body weight
Overall safety

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

515

participants targeted

Target at P75+ for phase_4 diabetes-mellitus-type-2

Timeline

Completed

Started Nov 2008

Typical duration for phase_4 diabetes-mellitus-type-2

Geographic Reach

17 countries

17 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.7 years study duration

First Submitted

Initial submission to the registry

September 10, 2008

Completed

1 day until next milestone

First Posted

Study publicly available on registry

September 11, 2008

Completed

2 months until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed

2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

August 15, 2012

Completed

Last Updated

September 10, 2012

Status Verified

September 1, 2012

Enrollment Period

2.7 years

First QC Date

September 10, 2008

Results QC Date

July 6, 2012

Last Update Submit

September 3, 2012

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

HbA1c: Change From Baseline to Study Endpoint
Change in HbA1c from baseline to study endpoint defined as the last available HbA1c value measured during the 24-week treatment period.
baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14

Secondary Outcomes (9)

HbA1c Response Rate: Percentage of Patients Who Reach the Target of HbA1c < 7% at Study Endpoint
study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14
HbA1c Response Rate: Percentage of Patients Who Reach the Target of HbA1c < 6.5% at Study Endpoint
study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14
Self-monitored Fasting Plasma Glucose (SMFPG) Mean : Change From Baseline to Study Endpoint
baseline (week 0), study endpoint: visit 14 (week 24) or visit 12 (week 16) or visit 11 (week 12) or visit 8 (week 6) depending on last available value
7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint
baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14
Insulin Dose in the Insulin Glargine Group
visit 4 (week 2), visit 8 (week 6), visit 11 (week 12), visit 12 (week 16), visit 14 (week 24), first dose received defined as first available value, study endpoint defined as last available value
+4 more secondary outcomes

Study Arms (2)

Insulin Glargine

EXPERIMENTAL

Administered once a day in the evening at dinner or at bedtime with a starting dose 0.2 U/kg. Then, the doses were to be individually adjusted, following a titration algorithm, to reach the FPG target: 70mg/dL\<FPG≤100mg/dL (3.9mmol/L\<FPG≤5.5mmol/L).

Drug: Insulin GlargineDrug: Metformin

Sitagliptin

ACTIVE COMPARATOR

Dose of 100 mg once a day administered with or without food.

Drug: SitagliptinDrug: Metformin

Interventions

Insulin GlargineDRUG

Subcutaneous injection. 100 Units/mL solution for injection in a pre-filled SoloStar® pen (3 mL).

Also known as: Lantus®

Insulin Glargine

SitagliptinDRUG

Oral administration. 100 mg film-coated tablets.

Also known as: Januvia®

Sitagliptin

MetforminDRUG

Patients continued with metformin as usual oral anti-diabetic treatment.

Insulin GlargineSitagliptin

Eligibility Criteria

Age35 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

With type 2 diabetes diagnosed for at least 6 months,
Not previously treated with insulin,
On metformin for at least 3 months and a stable minimal dose of 1 g/day for at least 2 months
HbA1c ≥ 7 and \< 11 %,
Body Mass Index (BMI) between 25 and 45 kg/m² inclusively,
Ability and willingness to perform plasma glucose (PG) monitoring using the Sponsor-provided PG meter and to complete the patient diary,
Signed informed consent obtained prior any study procedures,
Willingness and ability to comply with the study protocol.

You may not qualify if:

Treatment with oral antidiabetic drugs other than metformin within the last 3 months,
Previous treatment with the combination of metformin + sulfonylurea for more than 1 year,
Previous treatment with Glucagon Like Peptide-1 (GLP-1) agonists or DiPeptidyl Peptidase (DPP) IV inhibitors,
FPG (assessed by central laboratory measurement) ≥ 280 mg/dL (15.4 mmol/L),
Diabetes other than type 2 diabetes (e.g. secondary to pancreatic disorders, drug or chemical agents intake...),
Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method),
In-patient care,
Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study (an optic fundus examination should have been performed within the 2 years prior to study entry),
Impaired renal function: serum creatinine ≥ 1.5 mg/dL (≥ 133µmol/L) or ≥ 1.4 mg/dL (≥ 124 µmol/L) in men and women, respectively,
History of sensitivity to the study drugs or to drugs with a similar chemical structure,
Impaired hepatic function: alanine aminotransferase (ALT), aspartate aminotransferase (AST) \> 3 x upper limit of normal range,
Treatment with systemic corticosteroids within the 3 months prior to study entry or likelihood of requiring treatment during the study that are not permitted during the study (exception: in case of chronic adrenal insufficiency, systemic glucosteroids are accepted only if the disease is stable and the treatment dose stable for at least 3 months before study entry),
Alcohol or drug abuse within the last year,
Night shift worker,
Presence of any condition (medical, psychological, social or geographical), current or anticipated that the investigator feels would compromise the patient's safety or limit the patient successful participation in the study,
+3 more criteria

Contact the study team to confirm eligibility.