Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Linagliptin · 11 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. 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.
HbA1c is measured as a percentage. Adjusted for treatment, baseline HbA1c, categorical renal function impairment and concomitant Oral antidiabetic drugs (OAD)
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 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 | patients receive linagliptin 5 mg tablets once daily |
| placebo | PLACEBO_COMPARATOR | patients receive placebo tablets matching linagliptin 5 mg once daily |
| 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 | - |
| 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 | patients receive placebo matching linagliptin 5 mg once daily |
| 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 |
| 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 is a small molecule drug being developed for Type 2 Diabetes Mellitus and has been studied in healthy subjects. It is in Phase 3 clinical development by Eli Lilly and Company. The drug has been evaluated in 11 completed trials with a total enrollment of 11,124 participants.
Linagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor that works by blocking the enzyme DPP-4, which degrades incretin hormones. This increases active incretin levels, helping to regulate blood glucose by enhancing insulin secretion and reducing glucagon release in a glucose-dependent manner.
Linagliptin is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker symbol LLY. The drug is in Phase 3 clinical development for Type 2 Diabetes Mellitus.
Linagliptin is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug has completed 11 clinical trials, with no active trials currently ongoing.
Linagliptin has been studied in 11 completed clinical trials. Notable trials include NCT01204294, a Phase 3 study in Japan for Type 2 Diabetes Mellitus, and several Phase 1 bioequivalence studies in healthy subjects, such as NCT02084082 and NCT02121509, which tested fixed-dose combination tablets with metformin.
Linagliptin is the generic name for the drug marketed as Tradjenta. It is a DPP-4 inhibitor used for the treatment of Type 2 Diabetes Mellitus. The drug is being developed by Eli Lilly and Company and is currently in Phase 3 clinical trials.