Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Linagliptin
Linagliptin/Metformin · 12 trials · 1 indication
The number of patient with any AEs, patients with severe AE, patients with AEs leading to discontinuation of trial drug, and patients with Hypoglycaemic events
HbA1c is measured as a percentage. The change from baseline is the Week 30 HbA1c minus the baseline HbA1c.
HbA1c is measured as a percentage. Adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant Oral antidiabetic drugs (OAD)
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 24 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c and prior use of insulin.
HbA1c is measured as a percentage. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the baseline HbA1c percent. Means are treatment adjusted for baseline HbA1c, renal function impairment and prior use of antidiabetic agents.
Change from baseline in Glycosylated haemoglobin A1c (HbA1c) at Week 24 was calculated as: HbA1c at Week 24 - HbA1c at baseline. Baseline is referred to the last observed measurement prior to the administration of randomized trial medication. Adjusted mean (Least square mean) and its standard error (SE) is presented.
Change from baseline in Glycated haemoglobin (HbA1c) \[%\] after 24 weeks of treatment with double-blind trial medication. Baseline was defined as the last observation before the first intake of any double-blind randomised trial medication. The term 'baseline' was not used to refer to measurements before the administration of open-label medication.
The change from baseline in HbA1c after 24 weeks of treatment in main group. The mean was adjusted by baseline HbA1c and treatment group.
The change from baseline in HbA1c after 24 weeks of treatment in main group. Only subjects from the FAS with measured HbA1c values (observed cases \[OC\]) were considered. The mean was adjusted by treatment, baseline HbA1c, week and treatment\*week. The sensitivity analysis was added as the primary analysis failed with borderline results.
The change from baseline in HbA1c after 12 weeks of treatment in additional parallel group (APG) The mean was adjusted by baseline HbA1c and treatment group.
The first occurrence of any of the following Clinical Event Committee (CEC) confirmed adjudicated components of the primary composite endpoint: CV death (including fatal stroke and fatal myocardial infarction (MI)), non-fatal MI (excluding silent MI), or nonfatal stroke is presented.
Means are treatment adjusted for baseline HbA1c and previous anti-diabetic medication.
Glycosylated hemoglobin is reported as a percentage of the total hemoglobin
| Arm | Type | Description |
|---|---|---|
| Bigu+Lina | EXPERIMENTAL | biguanide plus linagliptin |
| Glin+Lina | EXPERIMENTAL | glinide plus linagliptin |
| Glit+Lina | EXPERIMENTAL | glitazone plus linagliptin |
| SU+Lina | EXPERIMENTAL | sulfonylurea plus linagliptin |
| A-GI+Lina | EXPERIMENTAL | alpha-glucosidase inhibitor plus linagliptin |
| SU+Met | ACTIVE_COMPARATOR | sulfonylurea plus metformin |
| A-GI+Met | ACTIVE_COMPARATOR | alpha-glucosidase inhibitor plus metformin |
| Pioglitazone 15 mg | ACTIVE_COMPARATOR | Pioglitazone Capsules 15 mg once daily |
| Pioglitazone 30 mg | ACTIVE_COMPARATOR | Pioglitazone Capsules 30 mg once daily |
| Pioglitazone 45 mg | ACTIVE_COMPARATOR | Pioglitazone Capsules 45 mg once daily |
| Linagliptin 5mg | ACTIVE_COMPARATOR | Linagliptin 5mg Tablets once daily |
| Linagliptin 5mg / Pioglitazone 15 mg | EXPERIMENTAL | Linagliptin 5mg / Pioglitazone 15 mg Tablets once daily |
| Linagliptin 5mg / Pioglitazone 30 mg | EXPERIMENTAL | Linagliptin 5mg / Pioglitazone 30 mg Tablets once daily |
| Linagliptin 5mg / Pioglitazone 45 mg | EXPERIMENTAL | Linagliptin 5mg / Pioglitazone 45 mg Tablets once daily |
| Linagliptin | EXPERIMENTAL | patient receives a tablet with intended final marketed dose |
| Placebo | PLACEBO_COMPARATOR | patient receives a tablet identical to those containing Linagliptin |
| Glimepiride | ACTIVE_COMPARATOR | Placebo patients switch to glimepiride after 12 weeks (40 weeks treatment) |
| Empagliflozin + linagliptin low dose | EXPERIMENTAL | patient to receive one tablet once daily |
| Empagliflozin + linagliptin high dose | EXPERIMENTAL | patient to receive one tablet once daily |
| Linagliptin placebo | PLACEBO_COMPARATOR | - |
| Empagliflozin + linagliptin high dose placebo | PLACEBO_COMPARATOR | - |
| Empagliflozin + linagliptin low dose placebo | PLACEBO_COMPARATOR | - |
| linagliptin2.5mg / metformin500mg BID | EXPERIMENTAL | patient to receive a tablet containing linagliptin 2.5mg and metformin 500mg BID |
| linagliptin2.5mg / metformin1000mg BID | EXPERIMENTAL | patient to receive a tablet containing linagliptin 2.5mg and metformin 1000mg BID |
| metformin 500mg BID | ACTIVE_COMPARATOR | patient to receive a tablet containing metformin 500mg BID |
| metformin 1000mg BID | ACTIVE_COMPARATOR | patient to receive a tablet containing metformin 1000mg BID |
| linagliptin 5 mg QD | ACTIVE_COMPARATOR | patient to receive a tablet containing linagliptin 5mg once daily |
| glimepiride 1-4 mg QD | ACTIVE_COMPARATOR | patient to receive glimepiride 1-4 mg or linagliptin placebo tablet Quaque die (QD) |
| Name | Type | Description |
|---|---|---|
| Linagliptin | DRUG | Linagliptin once daily |
| Metformin | DRUG | Metformin twice or three time per day |
| Pioglitazone 15 mg | DRUG | Pioglitazone Capsules 15 mg once daily for 30 weeks followed by Pioglitazone Capsules 30 mg once daily for up to 54 weeks |
| Pioglitazone 45 mg | DRUG | Pioglitazone Capsules 30 mg once daily for 6 weeks followed by Pioglitazone Capsules 45 mg once daily for up to 78 weeks |
| Pioglitazone 30 mg | DRUG | Pioglitazone Capsules 30 mg once daily for up to 84 weeks |
| Linagliptin 5mg / Pioglitazone 45 mg FDC | DRUG | Linagliptin 5mg low dose / Pioglitazone 30 mg Tablets once daily for 6 weeks followed by Linagliptin 5mg low dose / Pioglitazone 45 mg FDC Tablets once daily for up to 78 weeks |
| Linagliptin 5mg / Pioglitazone 30 mg FDC | DRUG | Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 84 weeks |
| Linagliptin 5mg | DRUG | Linagliptin 5mg Tablets low dose once daily for 30 weeks followed by Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 54 weeks |
| Linagliptin 5mg / Pioglitazone 15 mg FDC | DRUG | Linagliptin 5mg low dose / Pioglitazone 15 mg FDC Tablets once daily for 30 weeks followed by Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 54 weeks |
| Placebo | DRUG | Placebo, identical to Linagliptin tablet |
| Glimepiride | DRUG | 1-4 mg daily after 12 weeks |
| Empagliflozin placebo + linagliptin placebo low dose | DRUG | Matching placebo empagliflozin + linagliptin |
| Empagliflozin + linagliptin low dose | DRUG | tablet |
| Linagliptin placebo | DRUG | Matching placebo linagliptin |
| Empagliflozin + linagliptin high dose | DRUG | tablet |
| Empa + lina highdose placebo | DRUG | - |
| Empagliflozin + Linagliptin | DRUG | Fixed dose combination. |
| Empagliflozin placebo + Linagliptin placebo | DRUG | Matching Empagliflozin + Linagliptin low dose |
| linagliptin2.5mg/metformin1000mg | DRUG | linagliptin2.5mg/metformin1000mg BID |
| Metformin 500mg | DRUG | Metformin 500mg BID |
| linagliptin2.5mg/metformin500mg | DRUG | linagliptin2.5mg/metformin500mg BID |
| Metformin 1000mg | DRUG | Metformin 1000mg BID |
| glimepiride placebo | DRUG | glimepiride placebo |
Inclusion criteria: 1. Diagnosis of type 2 diabetes mellitus 2. Male and female patients on diet and exercise regimen who are treated with one antidiabetic drug Exclusion criteria: 1. Myocardial infarction, stroke, transient ischemic attack, or pulmonary embolism 2. Impaired hepatic function 3. G...
Linagliptin/Metformin is used to treat type 2 diabetes mellitus. It combines linagliptin, a DPP4 inhibitor, with metformin in a fixed-dose combination. The Phase 3 program studied the fixed-dose combination in drug-naive type 2 diabetes patients, including a trial conducted in China, Malaysia, the Philippines, and Vietnam.
Linagliptin is a DPP4 inhibitor, meaning it blocks the dipeptidyl peptidase-4 enzyme. Metformin is a separate oral glucose-lowering agent. The fixed-dose combination pairs the DPP4 inhibitor linagliptin with metformin to address type 2 diabetes through these two distinct mechanisms.
Eli Lilly and Company, which trades under the ticker LLY, is the developer of Linagliptin/Metformin. The company sponsored the Phase 3 clinical program for the fixed-dose combination in type 2 diabetes mellitus.
Linagliptin/Metformin has been studied in Phase 3 clinical development for type 2 diabetes mellitus. Twelve trials are recorded, all of which are completed, with no active trials. The program enrolled approximately 12,000 participants across randomized, double-blind, active-controlled studies.
The Phase 3 program includes NCT01708902, which compared the fixed-dose combination of linagliptin plus metformin in drug-naive type 2 diabetes patients, and NCT01243424, the CAROLINA cardiovascular outcome study of linagliptin versus glimepiride. Other completed trials include NCT02453555 and NCT01734785, which evaluated linagliptin with empagliflozin.
Linagliptin/Metformin is a fixed-dose combination that contains linagliptin, so it is not the same as linagliptin alone. Related names include Linagliptin/Metformin ER FDC, Linagliptin 5mg / Pioglitazone 45 mg FDC, Linagliptin/Pioglitazone, and linagliptin 2.5mg/metformin 1000mg.