New diabetes shot could cut injections in half
NCT ID NCT06849843
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tested a new drug called efsubaglutide alfa in 59 adults with type 2 diabetes whose blood sugar was not well controlled by diet and exercise alone. Participants received either a 3mg injection every two weeks or a 1mg injection weekly for 12 weeks. The goal was to see if the twice-monthly dose could lower blood sugar levels as effectively as the weekly dose.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Efsubaglutide Alfa injection
- What this could lead to
- If it works, this could offer a more convenient, less frequent injection option for managing type 2 diabetes.
- What could go wrong
- This is a small, early-phase trial with only 59 participants. The drug may not prove effective or could have side effects. Results may not apply to all diabetes patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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59 people
The number who actually took part.
- Started
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Dec 2024
- Finished
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May 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Male or female patients aged from 18 to 75; 2. Type 2 diabetes diagonsed at least 8 weeks and has not received any glucose-lowering medication within 8 weeks prior to screening; 3. During screening, HbA1c: 7.0% ≤ HbA1c ≤ 11.0%; 4. Before randomization : 7.0% ≤ HbA1c ≤ 11.0%; 5. During screening and before randomization: FPG\< 13.9 mmol/L 6. 24 kg/m2 ≤ BMI ≤ 40 kg/m2; 7. Without birth plan and voluntarily take effective contraceptive measures; 8. Fully understood the study, voluntarily entered the study and signed the informed consent. Exclusion Criteria: 1. Diabetes other than Type 2; 2. Any DPP-4 inhibitors and / or GLP-1 analogues were used within 3 months before screening; 3. Continuous use of insulin for more than 14 days in the previous year; 4. C-Peptide \<0.3 nmol/L; 5. Diabetic ketoacidosis, diabetic lactic acidosis or hyperosmolar non ketonic diabetic coma occurred within 6 months before screening; 6. Unstable proliferative retinopathy or macular lesion, severe diabetic neuropathy, intermittent claudication or diabetic foot occurred within 6 months before screening; 7. Severe hypoglycemia occurred within 6 months before screening 8. Severe trauma infection or operation within one month before screening; 9. Blood donation or massive blood loss or transfusion within 3 months ; 10. Suspected active infection ; 11. Growth hormone therapy was performed within 6 months before screening; 12. Patients having received corticosteroid continuous ≥ 7 days through within 2 months ; 13. Use any drugs or surgery with weight control effect within 2 months; 14. weight change of more than 5% within 3 months; 15. mean systolic pressure (SBP) ≥ 160mmhg and / or DBP ≥ 90 mmHg at screening, or new/changed antihypertensive drugs or adjusted dosage of antihypertensive drugs within 4 weeks before screening or before induction period 16. with a history of severe cardiovascular disease, high risk of stroke/stroke within 6 months before screening; 17. with a history of acute or chronic pancreatitis, symptomatic gallbladder , pancreatic injury and other risk factors for pancreatitis, or with blood amylase and/or blood lipase ≥1.5 times the upper limit of normal (ULN) at the time of screening or before randomization; 18. Calcitonin level ≥50 ng/L (pg/mL) during screening; 19. with a history of medullary thyroid cancer, multiple endocrine neoplasm (Men) 2A or 2B syndrome, or related family history; 20. with clinically significant abnormal gastric emptying , severe chronic gastrointestinal diseases , long-term use of drugs that have a direct impact on gastrointestinal peristalsis , or having undergone gastrointestinal surgery within 6 months before screening, are not suitable to participate in this clinical study according to the evaluation of the researchers; 21. suffering from hematological diseases or any disease causing hemolysis or erythrocyte instability ; 22. Uncontrolled hyperthyroidism or hypothyroidism; 23. with hemoglobinopathy that may affect the determination of HbA1c levels; 24. HBsAg, HCV-Ab, HIV-Ab, TPAb or COVID-19 nucleic acid tested positive; 25. serious mental illness; 26. drinking more than 14 standard units weekly within 6 months before screening ; 27. a history of organ transplantation or other acquired or congenital immune system diseases; 28. allergic to the active ingredients (GLP-1 and GLP-1 analogues) of the study drug; 29. clear contraindications for the use of metformin; 30. Any of the following conditions: the pacemaker was installed when screened; no pacemaker was installed, but 12 lead ECG showed degree II or III atrioventricular block, long QT syndrome or QTc interval ≥ 450ms (fridericia formula was used to calculate QTCF); Patients with New York Heart Function Classification III or IV; Or other abnormal cardiac function with clinical significance that is not suitable for clinical research judged by researchers; 31. acute or chronic viral hepatitis, or whose laboratory examination indexes meet one of the following criteria at the time of screening or before randomization : alanine aminotransferase (ALT) level ≥ 2.5 fold ULN, aspartate aminotransferase (AST) ≥ 2.5 fold ULN, fasting triglyceride (TG) \> 5.7 mmol/L or 500 mg/dl; the glomerular filtration rate (EGFR) \< 60 ml/min/1.73 m2 was calculated by CKD-EPI (epi - (SCR)) formula; 32. participated in clinical trials of other drugs or devices within 3 months before screening; 33. Medication compliance in the lead-in period was ≤ 50% ; 34. Any other situation that researchers think may affect the patients' informed consent or compliance with the trial protocol, or the patients' participation in the trial may affect the trial results or their own safety.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CangZhou Hospital of Integrated TCM and Western Medicine in Hebei Province
Cangzhou, China
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Huzhou Central Hospital
Huzhou, China
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Jiangsu Province Offical Hospital
Nanjing, China
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Nanjing First Hospital
Nanjing, Jiangsu, 210008, China
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Ningbo First Hospital
Ningbo, China
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Ningbo Medical Center Lihuili Hospital
Ningbo, China
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The First Affiliated Hospital of Soochow University
Suzhou, China
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The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
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Wenzhou Central Hospital
Wenzhou, China
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Zibo Municipal Hospital
Zibo, China
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