Shudi Insulin Injection (long-acting basal insulin analog) / Jiangsu Hengrui Pharma - LARVOL DELTA

Pharmacokinetics and safety of HR17031, a fixed-ratio of INS068/Noiiglutide combination, in Chinese patients with hepatic impairment. (PubMed, Diabetes Obes Metab) - "HR17031 demonstrated PK profiles of INS068 and Noiiglutide comparable between subjects with mild or moderate hepatic impairment and those with normal hepatic function, with modest reductions in moderate impairment. The treatment was well tolerated with a favourable safety profile, and no significant differences in C-peptide concentrations were observed across groups."

Journal • PK/PD data • Hepatology

Population Pharmacokinetic and Pharmacodynamic Modeling to Support Molar Dose Ratio Determination of Long-Acting Insulin Analogs. (PubMed, Clin Pharmacokinet) - "This analysis supported molar dose ratio of INS068 to IDeg as 1. INS068 had similar potency compared to IDeg, with one unit of INS068 composed of 6 nmol of active ingredient (1 U = 6 nmol)."

Journal • PK/PD data • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

Efficacy and safety of a once-daily basal insulin (insulin sudelidec) vs insulin glargine in type 2 diabetes inadequately controlled with basal insulin (EASD 2025) - P3 | "INS068 demonstrated similar efficacy as IGlar, with a significantly lower risk of overall nocturnal hypoglycemia, in T2D patients inadequately controlled with basal insulin."

Clinical • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and safety of a once-daily basal insulin (insulin sudelidec) vs insulin glargine in type 2 diabetes inadequately controlled with oral antidiabetic drugs (EASD 2025) - P3 | "INS068 demonstrated similar efficacy as IGlar, with significantly lower incidence of overall hypoglycemia and overall nocturnal hypoglycemia after 52-week treatment, in uncontrolled T2D with OADs in China."

Clinical • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and safety benefits of HR17031, a fixed-ratio combination of INS068 and noiiglutide, versus its components alone in Chinese patients with type 2 diabetes uncontrolled on oral antidiabetic drug(s): A phase 2, multicentre, open-label, randomised, parallel three-arm, treat-to-target trial. (PubMed, Diabetes Obes Metab) - "HR17031 is effective and well-tolerated in patients with type 2 diabetes uncontrolled on metformin with or without a second oral antidiabetic drug."

Journal • P2 data • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

To Compare the Efficacy and Safety of INS068 and Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin. (clinicaltrials.gov) - P3 | N=423 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Oct 2024 ➔ Jun 2024 | Trial primary completion date: Oct 2024 ➔ Jun 2024

Trial completion • Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

To Compare the Efficacy and Safety of INS068 and Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Not Adequately Controlled With Oral Antidiabetic Drugs (clinicaltrials.gov) - P3 | N=513 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Sep 2025 ➔ Nov 2024 | Trial primary completion date: Sep 2025 ➔ Nov 2024

Trial completion • Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Benefits of HR17031, a Fixed-Ratio Combination of INS068 and SHR20004, vs. Its Components Alone in Patients (pts) with Type 2 Diabetes (T2D) Uncontrolled on Oral Antidiabetic Drug(s) (OADs) (ADA 2024) - "This trial assessed efficacy and safety of HR17031 vs INS068 and SHR20004 in pts with T2D. In this randomized phase 2 trial, 455 Chinese adults with T2D (HbA1c 7.5%-11.0%; previous metformin±another OAD) were randomized (2:2:1) to daily injections of HR17031 (n = 183), INS068 (n = 182) or SHR20004 (0.12 mg/d; n = 90). HR17031 is effective and well-tolerated in pts with T2D uncontrolled on OAD(s)."

Clinical • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Pharmacokinetics and bioavailability of a new long-acting insulin analog in healthy Chinese volunteers: an open, randomized, single-dose, two-period and two-sequence cross-over study. (PubMed, Front Pharmacol) - P1 | " The overall PK profile of the two formulations of INS068 injection was comparable in healthy subjects, and the pen injector of INS068 had adequate safety and tolerability, supporting it as a new formulation in a phase III study and bridging PK data from early phase clinical trials. Clinical Trial Registration: clinicaltrials.gov, identifier: NCT05336071."

Journal • PK/PD data

To Compare the Efficacy and Safety of INS068 and Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Not Adequately Controlled With Oral Antidiabetic Drugs (clinicaltrials.gov) - P3 | N=513 | Active, not recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Enrolling by invitation ➔ Active, not recruiting

Enrollment closed • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

To Compare the Pharmacokinetics and Pharmacodynamics of HR20014, INS068 and INS062 After Single Subcutaneous Injection in Healthy Subjects (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Completed

Trial completion • Diabetes • Metabolic Disorders

The Relative Bioavailability of INS068 Injection With Two Different Formulations in Healthy Subjects (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Diabetes • Metabolic Disorders

To Compare the Pharmacokinetics and Pharmacodynamics of HR20014, INS068 and INS062 After Single Subcutaneous Injection in Healthy Subjects (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P1 trial • Diabetes • Metabolic Disorders

To Compare the Efficacy and Safety of INS068 and Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin. (clinicaltrials.gov) - P3 | N=400 | Recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Trial Comparing the Efficacy and Safety of HR17031 Injection to INS068 Injection and to SHR20004 Injection in Patients With Type 2 Diabetes (clinicaltrials.gov) - P2 | N=455 | Active, not recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

To Compare the Efficacy and Safety of INS068 and Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Not Adequately Controlled With Oral Antidiabetic Drugs (clinicaltrials.gov) - P3 | N=501 | Enrolling by invitation | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

To Compare the Efficacy and Safety of INS068 and Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin. (clinicaltrials.gov) - P3 | N=400 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P3 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

To Compare the Efficacy and Safety of INS068 and Insulin Glargine in Subjects With Type 2 Diabetes Mellitus Not Adequately Controlled With Oral Antidiabetic Drugs (clinicaltrials.gov) - P3 | N=501 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P3 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Trial of INS068 in Patients With Type 2 Diabetes Not Adequately Controlled With One or Two Oral Antidiabetics (clinicaltrials.gov) - P2 | N=179 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Pharmacokinetics of HR17031 Injection in Healthy Subjects (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Trial Comparing the Efficacy and Safety of HR17031 Injection to INS068 Injection and to SHR20004 Injection in Patients With Type 2 Diabetes (clinicaltrials.gov) - P2 | N=450 | Recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

The Relative Bioavailability of INS068 Injection With Two Different Formulations in Healthy Subjects (clinicaltrials.gov) - P1 | N=24 | Active, not recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Diabetes • Metabolic Disorders

The Relative Bioavailability of INS068 Injection With Two Different Formulations in Healthy Subjects (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P1 trial • Diabetes • Metabolic Disorders

A Trial Comparing the Efficacy and Safety of HR17031 Injection to INS068 Injection and to SHR20004 Injection in Patients With Type 2 Diabetes (clinicaltrials.gov) - P2 | N=450 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

New P2 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Trial of INS068 in Patients With Type 2 Diabetes Not Adequately Controlled With One or Two Oral Antidiabetics (clinicaltrials.gov) - P2 | N=179 | Active, not recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus